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  • Dispositivo 153
  • Fabricante 42
  • Evento 124969
  • Implante 0
Device Recall Spacelabs Medical Patient Monitor equipped with the Perioperative Option
  • Modelo / Serial
    The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US. These 15 units will receive serial numbers after the software upgrade is installed.   THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US:  040-1548-00, 1367-000033, 1369-001517, 1369-003051, 1369-003077, 1369-004247, 1369-005914, 1369-006877, 1369-007165, 1369-008519, 1369-010292, 1369-011637, 1369-017520, 1369-061217, 1370-000013, 1370-000014, 1370-000025, 1370-000095, 1370-000285, 1370-000449, 1370-000471, 1370-000579, 1370-000658, 1370-001700, 1370-002494, 1370-002510, 1370-003785, 1370-004176, 1370-004184, 1370-004275, 1370-004292, 1387-000465, 1387-000535, 1387-000543, 1387-001071, 1387-001677, 1387-006200, 1387-010824, 1387-010830, 1387-011914, 1387-014142, 1387-014159, 1387-014184, 1387-014186, 1387-014187, 1387-014188, 1387-014596, 1387-015721, 1387-015722, 1387-015723, 1387-016045, 1387-018424, 1387-018947, 1387-019766, 1387-019768, 1387-019769, 1387-019771, 1387-019772, 1387-100036, 1387-101646, 1387-104672, 1387-105801, 1387-105811, 1387-105812, 1387-105882, 1393-000442, 1393-000579, 1393-000580, 1393-000581, 1393-000582, and 387-002421.   THERE ARE 137 SERIAL NUMBERS IDENTIFIED ON UNITS DISTRIBUTED OUTSIDE OF THE US:  1369-000011, 1369-000165, 1369-000407, 1369-000928, 1369-002976, 1369-003388, 1369-005316, 1369-005334, 1369-006100, 1369-006281, 1369-007338, 1369-009142, 1369-009143, 1369-009144, 1369-009145, 1369-009146, 1369-009889, 1369-009890, 1369-011741, 1369-011742, 1369-011743, 1369-011744, 1369-011745, 1369-013721, 1369-016648, 1369-016649, 1369-017759, 1369-017791, 1369-017792, 1370-000026, 1370-000725, 1370-000771, 1370-002373, 1370-002378, 1370-002380, 1370-002381, 1370-002382, 1370-002383, 1370-002384, 1370-003809, 1370-004133, 1370-004277, 1370-004509, 1370-004510, 1370-004511, 1370-004516, 1370-004617, 1370-200366, 1370-200370, 1370-200374, 1370-200375, 1370-200376, 1370-200378, 1370-200380, 1370-200471, 1370-200473, 1370-200474, 1370-200475, 1370-200476, 1370-200691, 1387-000044, 1387-000447, 1387-000467, 1387-000548, 1387-001086, 1387-002157, 1387-005006, 1387-008003, 1387-008310, 1387-010742, 1387-013241, 1387-013716, 1387-014610, 1387-018104, 1387-018105, 1387-018171, 1387-018176, 1387-018277, 1387-018638, 1387-018817, 1387-019563, 1387-100148, 1387-100150, 1387-100151, 1387-100155, 1387-100906, 1387-101061, 1387-101062, 1387-101063, 1387-101064, 1387-101065, 1387-101066, 1387-101067, 1387-102222, 1387-103550, 1387-103659, 1387-104462, 1387-105831, 1387-105832, 1387-105833, 1387-105834, 1393-000013, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000808, 1393-000809, 1393-000822, 1393-000831, 1393-000833, 1393-000834, 1393-000851, 1393-000852, 1393-00235, 1393-00236, 1393-00237, 1393-00238, 1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346, 1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351, 1393-00352, 1393-00353, 1393-00354, AND 1393-00355.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.
  • Descripción del producto
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. || Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Medical Patient Monitor equipped with the Perioperative Option
Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281
  • Modelo / Serial
    Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056.  Model 96281, with SpO2 Option C.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to TX.
  • Descripción del producto
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281
Device Recall Spacelabs Healthcare Ultraview SL Multigas Module
  • Modelo / Serial
    Serial Numbers: 2518-000183  2518-000184  2518-000185  2518-000186  2518-000206  2518-000207  2518-000208  2518-000209
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
  • Descripción del producto
    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare Ultraview SL Multigas Module
Device Recall Spacelabs Healthcare Qube Compact Monitor
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
  • Descripción del producto
    Spacelabs Healthcare Qube Compact Monitor, Model 91390. || Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare Qube Compact Monitor
Device Recall Spacelabs Healthcare Ventilator Flexport Interface
  • Modelo / Serial
    Serial Numbers Distributed in the US:  436A000660, 436A000663, 436A000664, 436A000666, 436A000667, 436A000669, 436A004306, 436A004307, 436A004308, 436A004309, 436A004310, 436A006122, 436A006123, 436A006441, 436A006442, 436A006443, 436A006444, 436A006452, 436A006573, 436A006589, 436A006590, 436A006591, 436A006592, 436A006593, 436A006594, 436A006595, 436A006596, 6A006597, 436A006598, 436A006599, 436A006600, 436A006601, 436A00670, 436A006966 436A01020, 436A02086, 436A02087, 436A02088, 436A02234, 436A02246, 436A02247, 436A02281, 436A02282, 436A02283, 436A03237 and 436A03238.   Serial Numbers Distributed Outside the US: 436A003628, 436A003629, 436A003630, 436A003631, 436A003632, 436A003633, 436A003634, 436A003635, 436A003636, 436A003637, 436A003638, 436A003639, 436A003640, 436A003644, 436A003645, 436A003646, 436A003647, 436A004162, 436A004166, 436A004197,  436A004198, 436a005205, 436a005471, 436a005472, 436A005638, 436A005641, 436A005642, 436A006087, 436A006088, 436A006151, 436A006193, 436A006248, 436A006249, 436A006250, 436A006262, 436A006389, 436A006390, 436A006397, 436A006445, 436A006446,  436A006522, 436A006523, 436A006524, 436A006570, 436A006571, 436A006572, 436A006609, 436A006610, 436A006611, 436A006612, 436A006613, 436A006614, 436A006616, 436A006617, 436A006618, 436A006619, 436A006620, 436A006621, 436A006624, 436A006625,  436A006950, 436A006951, 436A01023, 436A01094, 436A01095, 436A01096, 436A01097, 436A01098, 436A01099, 436A01100, 436A01101, 436A01102, 436A01103, 436A01104, 436A01105, 436A01106, 436A01107, 436A01108, 436A01129, 436A01152, 436A01190, 436A01191, 436A01192, 436A01193, 436A01194, 436A01195, 436A01197, 436A01199, 436A01200, 436A01212, 436A01213, 436A01217, 436A01298, 436A02023, 436A02024, 436A02025, 436A02026, 436A02027, 436A02188, 436A02233, 436A02262, 436A02264, 436A02590, 436A02591, 436A02592, 436A03193, 436A03239, and 436A03500.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
  • Descripción del producto
    Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare Ventilator Flexport Interface
Device Recall Ultraview SL Command Module
  • Modelo / Serial
    All devices of Model: 91496.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to GA.
  • Descripción del producto
    Spacelabs Medical Ultraview SL Command Module, Model 91496. || Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ultraview SL Command Module
Touchscreen Display Model 94267
  • Modelo / Serial
    Serial Number for U.S. Cosignees: PRO-12240004, PRO-12240015, PRO-12240017, PRO-12240018, PRO-12240022, PRO-12240026, PRO-12240028, PRO-12240030, PRO-12240031, PRO-12240032, PRO-12240033, PRO-12240034, PRO-12240036, PRO-12240037, PRO-12240038, PRO-12240040, PRO-12240041, PRO-12240058, PRO-12240059, PRO-12240062, PRO-12240063, PRO-12240077, PRO-12240084, PRO-12240090, pro-12260008, PRO-12260016, pro-12260018, PRO-12260023, pro-12260024, PRO-12260032, pro-12260033, pro-12260035, PRO-12260036, PRO-12260037, pro-12260038, pro-12260041, pro-12260044, pro-12260055, pro-12260059, PRO-12260060, PRO-12260062, pro-12260064, pro-12260065, pro-12260068, pro-12260070, pro-12260071, pro-12260073, PRO-12260076, PRO-12260077, PRO-12260080, PRO-12260081, PRO-12260082, PRO-12260083, PRO-12260085, PRO-12260086, PRO-12260087, PRO-12260088, PRO-12260092, PRO-12260094, PRO-12260096, PRO-12260097, pro-12260121, pro-12260125, pro-12260131, pro-12260164, pro-12260167, pro-12260172, PRO-12260175, PRO-12260183, pro-12260185, pro-12280036, pro-12280049, pro-12280062, pro-12280119, pro-12280121, pro-12280126, pro-12280127, pro-12280131, pro-12280133, pro-12280134, pro-12280136, pro-12280137, pro-12280152, pro-12280155, pro-12280156, pro-12280160, pro-12280161, pro-12280162, pro-12280163, pro-12280173, pro-12280174, pro-12280175, pro-12280177, pro-12280182, pro-12280205, pro-12280232, pro-12280272, pro-12280273.   Serial number for International Consignees:  PRO-12240056, PRO-12260005, pro-12260006, PRO-12260012, PRO-12260013, pro-12260019, PRO-12260020, PRO-12260021, pro-12260022, pro-12260025, pro-12260026, pro-12260027, pro-12260028, PRO-12260029, PRO-12260030, pro-12260031, PRO-12260040, PRO-12260043, PRO-12260045, PRO-12260046, pro-12260047, PRO-12260051, PRO-12260053, PRO-12260057, PRO-12260075, pro-12260079, PRO-12260111, PRO-12260118, PRO-12260122, pro-12260124, pro-12260128, pro-12260140, pro-12260143, PRO-12260146, PRO-12260147, PRO-12260149, PRO-12260151, PRO-12260152, PRO-12260153, PRO-12260155, PRO-12260156, PRO-12260157, pro-12260158, PRO-12260159, PRO-12260160, PRO-12260161, PRO-12260162, PRO-12260163, PRO-12260169, PRO-12260170, pro-12260171, pro-12260174, PRO-12260176, PRO-12260178, pro-12260179, pro-12260180, pro-12260182, pro-12260189, pro-12260190, pro-12260191, PRO-12260192, pro-12260193, pro-12260195, pro-12260199, pro-12280006, pro-12280023, pro-12280132, pro-12280135, pro-12280141, pro-12280206, pro-12280225.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and United Kingdom
  • Descripción del producto
    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. || The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Touchscreen Display Model 94267
Qube Compact Monitor Model 91390
  • Modelo / Serial
    Serial numbers for devices distributed in the US:  1390-000102, 1390-000103, 1390-000104, 1390-000105, 1390-000106, 1390-000107, 1390-000108, 1390-000109, 1390-000110, 1390-000111, 1390-000112, 1390-000113, 1390-000114, 1390-000115, 1390-000116, 1390-000119, 1390-000120, 1390-000150, 1390-000151, 1390-000152, 1390-000153, 1390-000154, 1390-000155, 1390-000156, 1390-000157, 1390-000158, 1390-000159, 1390-000160, 1390-000161, 1390-000162, 1390-000163, 1390-000164, 1390-000165, 1390-000166, 1390-000167, 1390-000168, 1390-000169, 1390-000170, 1390-000171, 1390-000172, 1390-000173, 1390-000174, 1390-000175, 1390-000176, 1390-000177, 1390-000178, 1390-000179, 1390-000180, 1390-000181, 1390-000182, 1390-000183, 1390-000184, 1390-000185, 1390-000186, 1390-000187, 1390-000188, 1390-000189, 1390-000190, 1390-000191, 1390-000192, 1390-000193, 1390-000195, 1390-000196, 1390-000197, 1390-000198, 1390-000199, 1390-000200, 1390-000201, 1390-000202, 1390-000203, 1390-000204, 1390-000205, 1390-000206, 1390-000207, 1390-000208, 1390-000209, 1390-000210, 1390-000211, 1390-000212, 1390-000213, 1390-000214, 1390-000215, 1390-000216, 1390-000217, 1390-000218, 1390-000219, 1390-000220, 1390-000221, 1390-000222, 1390-000223, 1390-000224, 1390-000225, 1390-000226, 1390-000227, 1390-000228, 1390-000229, 1390-000230, 1390-000231, 1390-000232, 1390-000233, 1390-000234, 1390-000235, 1390-000236, 1390-000237, 1390-000238, 1390-000239, 1390-000240, 1390-000241, 1390-000242, 1390-000243, 1390-000244, 1390-000245, 1390-000246, 1390-000247, 1390-000248, 1390-000249, 1390-000250, 1390-000251, 1390-000252, 1390-000253, 1390-000254, 1390-000255, 1390-000256, 1390-000257, 1390-000258, 1390-000259, 1390-000260, 1390-000261, 1390-000262, 1390-000263, 1390-000264, 1390-000266, 1390-000267, 1390-000268, 1390-000269, 1390-000270, 1390-000271, 1390-000272, 1390-000273, 1390-000274, 1390-000275, 1390-000276, 1390-000277, 1390-000278, 1390-000279, 1390-000280, 1390-000281, 1390-000282, 1390-000283, 1390-000284, 1390-000285, 1390-000286, 1390-000287, 1390-000288, 1390-000289, 1390-000296, 1390-000297, 1390-000298, 1390-000299, 1390-000300, 1390-000301, 1390-000302, 1390-000304, 1390-000305, 1390-000307, 1390-000308, 1390-000310, 1390-000311, 1390-000312, 1390-000314, 1390-000315, 1390-000316, 1390-000317, 1390-000318, 1390-000319, 1390-000321, 1390-000322, 1390-000323, 1390-000325, 1390-000341, 1390-000342, 1390-000343, 1390-000344, 1390-000345, 1390-000346, 1390-000347, 1390-000348, 1390-000349, 1390-000350, 1390-000351, 1390-000352, 1390-000353, 1390-000354, 1390-000355, 1390-000356, 1390-000357, 1390-000358, 1390-000359, 1390-000360, 1390-000361, 1390-000362, 1390-000363, 1390-000364, 1390-000365, 1390-000366, 1390-000367, 1390-000368, 1390-000369, 1390-000370, 1390-000371, 1390-000372, 1390-000373, 1390-000374, 1390-000375, 1390-000376, 1390-000377, 1390-000378, 1390-000379, 1390-000380, 1390-000381, 1390-000382, 1390-000383, 1390-000384, 1390-000385, 1390-000386, 1390-000387, 1390-000388, 1390-000389, 1390-000390, 1390-000391, 1390-000392, 1390-000393, 1390-000394, 1390-000420, 1390-000421, 1390-000422, 1390-000423, 1390-000424, 1390-000425, 1390-000426, 1390-000427, 1390-000428, 1390-000429, 1390-000430, 1390-000431, 1390-000432, 1390-000433, 1390-000434, 1390-000435, 1390-000436, 1390-000437, 1390-000438, 1390-000439, 1390-000440, 1390-000441, 1390-000442, 1390-000443, 1390-000444, 1390-000445, 1390-000446, 1390-000447, 1390-000448, 1390-000449, 1390-000450, 1390-000451, 1390-000452, 1390-000453, 1390-000454, 1390-000455, 1390-000456, 1390-000457, 1390-000458, 1390-000459, 1390-000460, 1390-000461, 1390-000462, 1390-000463, 1390-000464, 1390-000465, 1390-000467, 1390-000468, 1390-000469, 1390-000470, 1390-000483, 1390-000564, 1390-000582, 1390-000583, 1390-000584, 1390-000585, 1390-000586, 1390-000587, 1390-000588, 1390-000589, 1390-000590, 1390-000591, 1390-000592, 1390-000593, 1390-000594, 1390-000595, 1390-000597, 1390-000598, 1390-000599, 1390-000600, 1390-000601, 1390-000602, 1390-000603, 1390-000606, 1390-000614, 1390-000615, 1390-000616, 1390-000623, 1390-000624, 1390-000625, 1390-000626, 1390-000627, 1390-000628, 1390-000629, 1390-000630, 1390-000631, 1390-000632, 1390-000633, 1390-000634, 1390-000635, 1390-000636, 1390-000637, 1390-000638, 1390-000639, 1390-000640, 1390-000641, 1390-000642, 1390-000643, 1390-000644, 1390-000645, 1390-000646, 1390-000647, 1390-000648, 1390-000649, 1390-000650, 1390-000651, 1390-000652, 1390-000653, 1390-000654, 1390-000655, 1390-000656, 1390-000657, 1390-000658, 1390-000659, 1390-000660, 1390-000661, 1390-000662, 1390-000663, 1390-000664, 1390-000665, 1390-000666, 1390-000667, 1390-000668, 1390-000669, 1390-000670, 1390-000671, 1390-000672, 1390-000673, 1390-000674, 1390-000675, 1390-000676, 1390-000677, 1390-000678, 1390-000679, 1390-000680, 1390-000681, 1390-000682, 1390-000683, 1390-000684, 1390-000685, 1390-000686, 1390-000687, 1390-000688, 1390-000698, 1390-000699, 1390-000700, 1390-000701, 1390-000702, 1390-000703, 1390-000704, 1390-000705, 1390-000706, 1390-000707, 1390-000708, 1390-000710, 1390-000712, 1390-000713, 1390-000714, 1390-000720, 1390-000721, 1390-000728, 1390-000729, 1390-000730, 1390-000731, 1390-000732, 1390-000733, 1390-000734, 1390-000735, 1390-000736, 1390-000737, 1390-000738, 1390-000742, 1390-000743, 1390-000744, 1390-000745, 1390-000746, 1390-000747, 1390-000748, 1390-000749, 1390-000750, 1390-000751, 1390-000752, 1390-000753, 1390-000754, 1390-000755, 1390-000756, 1390-000757, 1390-000758, 1390-000759, 1390-000760, 1390-000761, 1390-000762, 1390-000763, 1390-000764, 1390-000765, 1390-000766, 1390-000767, 1390-000768, 1390-000769, 1390-000775, 1390-000776, 1390-000777, 1390-000778, 1390-000779, 1390-000780, 1390-000781, 1390-000782, 1390-000792, 1390-000793, 1390-000794, 1390-000795, 1390-000796, 1390-000800, 1390-000801, 1390-000802, 1390-000803, 1390-000804, 1390-000805, 1390-000806, 1390-000807, 1390-000808, 1390-000809, 1390-000810, 1390-000811, 1390-000812, 1390-000813, 1390-000814, 1390-000815, 1390-000816, 1390-000817, 1390-000818, 1390-000819, 1390-000820, 1390-000821, 1390-000822, 1390-000823, 1390-000824, 1390-000825, 1390-000826, 1390-000827, 1390-000828, 1390-000829, 1390-000830, 1390-000831, 1390-000832, 1390-000833, 1390-000834, 1390-000835, 1390-000836, 1390-000837, 1390-000838, 1390-000839, 1390-000840, 1390-000841, 1390-000842, 1390-000843, 1390-000844, 1390-000845, 1390-000846, 1390-000847, 1390-000848, 1390-000849, 1390-000850, 1390-000851, 1390-000852, 1390-000853, 1390-000854, 1390-000855, 1390-000856, 1390-000857, 1390-000858, 1390-000859, 1390-000860, 1390-000861, 1390-000862, 1390-000863, 1390-000870, 1390-000871, 1390-000872, 1390-000887, 1390-000888, 1390-000889, 1390-000890, 1390-000891, 1390-000892, 1390-000893, 1390-000894, 1390-000895, 1390-000896, 1390-000897, 1390-000898, 1390-000899, 1390-000900, 1390-000901, 1390-000902, 1390-000903, and 1390-000904.   Serial numbers for devices distributed INTERNATIONAL: On 4/16/13 the firm advised FDA that they added serial number 1390-000055 and 1390-000913.  1390-000290, 1390-000291, 1390-000337, 1390-000338, 1390-000339, 1390-000340, 1390-000607, 1390-000608, 1390-000609, 1390-000610, 1390-000689, 1390-000690, 1390-000691, 1390-000692, 1390-000693, 1390-000695, 1390-000536, 1390-000537, 1390-000709, 1390-000722, 1390-000723, 1390-000724, 1390-000725, 1390-000879, 1390-000880, 1390-000881, 1390-000905, 1390-000906, 1390-000907, 1390-000908, 1390-000909, 1390-000910 1390-000009, 1390-000010, 1390-000011, 1390-000012, 1390-000013, 1390-000014, 1390-000015, 1390-000016, 1390-000017, 1390-000018, 1390-000046, 1390-000048, 1390-000049, 1390-000051, 1390-000052, 1390-000053, 1390-000056, 1390-000057, 1390-000059, 1390-000060, 1390-000061, 1390-000062, 1390-000063, 1390-000101, 1390-000117, 1390-000118, 1390-000125, 1390-000127, 1390-000128, 1390-000138, 1390-000139, 1390-000140, 1390-000141, 1390-000142, 1390-000143, 1390-000144, 1390-000145, 1390-000146, 1390-000147, 1390-000148, 1390-000149, 1390-000326, 1390-000327, 1390-000328, 1390-000329, 1390-000330, 1390-000331, 1390-000332, 1390-000333, 1390-000334, 1390-000335, 1390-000336, 1390-000466, 1390-000535, 1390-000552, 1390-000568, 1390-000605, 1390-000611, 1390-000612, 1390-000613, 1390-000715, 1390-000716, 1390-000739, 1390-000740, 1390-000741, 1390-000770, 1390-000787, 1390-000788, 1390-000789, 1390-000790, 1390-000791, 1390-000797, 1390-000798, 1390-000876, 1390-000877, 1390-000878, 1390-1390-000047, 1390-00002, 1390-000618, 1390-000619, 1390-000620, 1390-000621, 1390-000622, 1390-000509, 1390-000510, 1390-000511, 1390-000512, 1390-000513, 1390-000514, 1390-000553, 1390-000554, 1390-000121, 1390-000524, 1390-000771, 1390-000772, 1390-000292, 1390-000293, 1390-000294, 1390-000295, 1390-000911, 1390-000555, 1390-000556, 1390-000557, 1390-000558, 1390-000559, 1390-000560, 1390-000561, 1390-000562, 1390-000563, 1390-000565, 1390-000566, 1390-000567, 1390-000569, 1390-000570, 1390-000571, 1390-000572, 1390-000573, 1390-000574, 1390-000575, 1390-000576, 1390-000577, 1390-000578, 1390-000579, 1390-000580, 1390-000581 1390-000395, 1390-000396, 1390-000397, 1390-000398, 1390-000399, 1390-000400, 1390-000401, 1390-000402, 1390-000403, 1390-000404, 1390-000405, 1390-000406, 1390-000407, 1390-000408, 1390-000409, 1390-000410, 1390-000411, 1390-000412, 1390-000413, 1390-000414, 1390-000415, 1390-000416, 1390-000417, 1390-000418, 1390-000419, 1390-000604, 1390-000130, 1390-000131, 1390-000132, 1390-000133, 1390-000135, 1390-000136, 1390-000137, 1390-000493, 1390-000496, 1390-000497, 1390-000498, 1390-000499, 1390-000500, 1390-000501, 1390-000502, 1390-000525, 1390-000526, 1390-000527, 1390-000528, 1390-000529, 1390-000530, 1390-000531, 1390-000532, 1390-000533, 1390-000534, 1390-000596, 1390-000617, 1390-000799, and 1390-000696.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.On 4/16/13 the firm advised FDA that they added serial number 1390-000055 and 1390-000913. The two additional serial numbers were added because they were provided as replacements to a French customer whose devices had been returned to support the firm's investigation. The customer had already received the Urgent Medical Device correction, customer letter and required Spacelabs to provide these devices with the understanding that they would require the field corrective action
  • Descripción del producto
    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. || The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Qube Compact Monitor Model 91390
Device Recall Ultraview SL Patient Monitor, Model 91387
  • Modelo / Serial
    Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx).
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, Republic OF CHINA, Thailand, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.
  • Descripción del producto
    Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. || Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx). || The data sheet is labeled in part: || "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria¿ system interfaces. The SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***". || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow net worked based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ultraview SL Patient Monitor, Model 91387
Device Recall Spacelabs Medical Flat Panel Display
  • Modelo / Serial
    Date Codes (WK numbers) identified on the affected power supplies:  0647, 0703, 0706, 0707, 0709, 0712, 0724, 0727, 0728 or 0732.  Lot/Serial Numbers on the systems for US Consignees:  ELZ-0011442, ELZ-0012143, ELZ-0013307, ELZ-0013557, ELZ-0014567,  ELZ-0014570, ELZ-0014574, ELZ-0014577, ELZ-0014580, ELZ-0014583,  ELZ-0014585, ELZ-0014586, ELZ-0014587, ELZ-0014590, ELZ-0014591,  ELZ-0014592, ELZ-0014593, ELZ-0014594, ELZ-0014595, ELZ-0014596,  ELZ-0014597, ELZ-0014598, ELZ-0014599, ELZ-0014600, ELZ-0014601,  ELZ-0014603, ELZ-0014604, ELZ-0014605, ELZ-0014606, ELZ-0014607,  ELZ-0014608, ELZ-0014609, ELZ-0014610, ELZ-0014611, ELZ-0014612,  ELZ-0014613, ELZ-0014614, ELZ-0014615, ELZ-0014616, ELZ-0014617,  ELZ-0014618, ELZ-0014619, ELZ-0014620, ELZ-0014621, ELZ-0014622,  ELZ-0014623, ELZ-0014625, ELZ-0014626, ELZ-0014629, ELZ-0014630,  ELZ-0014631, ELZ-0014632, ELZ-0014633, ELZ-0014634, ELZ-0014635,  ELZ-0014636, ELZ-0014637, ELZ-0014638, ELZ-0014639, ELZ-0014640,  ELZ-0014641, ELZ-0014645, ELZ-0014648, ELZ-0014656, ELZ-0014657,  ELZ-0014658, ELZ-0014718, ELZ-0014719, ELZ-0014720, ELZ-0014723,  ELZ-0014724, ELZ-0014726, ELZ-0014727, ELZ-0014729, ELZ-0014731,  ELZ-0014733, ELZ-0014736, ELZ-0014737, ELZ-0014738, ELZ-0014740,  ELZ-0014742, ELZ-0014744, ELZ-0014745, ELZ-0014750, ELZ-0014752,  ELZ-0014754, ELZ-0014755, ELZ-0014756, ELZ-0014758, ELZ-0014759,  ELZ-0014760, ELZ-0014762, ELZ-0014764, ELZ-0014765, ELZ-0014766,  ELZ-0014767, ELZ-0014768, ELZ-0014770, ELZ-0014771, ELZ-0014772, ELZ-0014773, ELZ-0014774, ELZ-0014775, ELZ-0014776, ELZ-0014780, ELZ-0014781, ELZ-0014782, ELZ-0014783, ELZ-0014786, ELZ-0014787, ELZ-0014788, ELZ-0014790, ELZ-0014791, ELZ-0014795, ELZ-0014800, ELZ-0014805, ELZ-0014806, ELZ-0014810, ELZ-0014816, ELZ-0014817, ELZ-0014819, ELZ-0014820, ELZ-0014823, ELZ-0014824, ELZ-0014827, ELZ-0014828, ELZ-0014833, ELZ-0014834, ELZ-0014836, ELZ-0014837, ELZ-0014839, ELZ-0014842, ELZ-0014846, ELZ-0014852, ELZ-0014853, ELZ-0014854, ELZ-0014857, ELZ-0014858, ELZ-0014859, ELZ-0014861, ELZ-0014863, ELZ-0014864, ELZ-0014865, ELZ-0014866, ELZ-0014867, ELZ-0014868, ELZ-0014869, ELZ-0014872, ELZ-0014873, ELZ-0014874, ELZ-0014875, ELZ-0014876, ELZ-0014877, ELZ-0014878, ELZ-0014879, ELZ-0014880, ELZ-0014881, ELZ-0014882, ELZ-0014883, ELZ-0014885, ELZ-0014886, ELZ-0014890, ELZ-0014891, ELZ-0014892, ELZ-0014893, ELZ-0014894, ELZ-0014895, ELZ-0014896, ELZ-0014900, ELZ-0014902, ELZ-0014905, ELZ-0014906, ELZ-0014910, ELZ-0014913, ELZ-0014914, ELZ-0014915, ELZ-0014916, ELZ-0014917, ELZ-0014920, ELZ-0014922, ELZ-0014925, ELZ-0014926, ELZ-0014927, ELZ-0014930, ELZ-0014931, ELZ-0014933, ELZ-0014934, ELZ-0014935, ELZ-0014936, ELZ-0014937, ELZ-0014938, ELZ-0014940, ELZ-0014941, ELZ-0014942, ELZ-0014943, ELZ-0014944, ELZ-0014945, ELZ-0014947, ELZ-0014949, ELZ-0014950, ELZ-0014951, ELZ-0014953, ELZ-0014954, ELZ-0014955, ELZ-0014956, ELZ-0014957, ELZ-0014958, ELZ-0014959, ELZ-0014960, ELZ-0014961, ELZ-0014964, ELZ-0014965, ELZ-0014968, ELZ-0014969, ELZ-0014972, ELZ-0014973, ELZ-0014974, ELZ-0014975, ELZ-0014976, ELZ-0014977, ELZ-0014979, ELZ-0014981, ELZ-0014982, ELZ-0014983, ELZ-0014985, ELZ-0014986, ELZ-0014987, ELZ-0014989, ELZ-0014992, ELZ-0014994, ELZ-0014995, ELZ-0014996, ELZ-0014999, ELZ-0015000, ELZ-0015001, ELZ-0015002, ELZ-0015005, ELZ-0015006, ELZ-0015007, ELZ-0015008, ELZ-0015009, ELZ-0015010, ELZ-0015011, ELZ-0015012, ELZ-0015013, ELZ-0015014, ELZ-0015015, ELZ-0015016, ELZ-0015017, ELZ-0015018, ELZ-0015019, ELZ-0015020, ELZ-0015021, ELZ-0015022, ELZ-0015023, ELZ-0015024, ELZ-0015025, ELZ-0015026, ELZ-0015027, ELZ-0015028, ELZ-0015029, ELZ-0015030, ELZ-0015031, ELZ-0015032, ELZ-0015033, ELZ-0015034, ELZ-0015035, ELZ-0015036, ELZ-0015037, ELZ-0015038, ELZ-0015039, ELZ-0015040, ELZ-0015042, ELZ-0015043, ELZ-0015044, ELZ-0015045, ELZ-0015046, ELZ-0015047, ELZ-0015048, ELZ-0015050, ELZ-0015051, ELZ-0015052, ELZ-0015053, ELZ-0015054, ELZ-0015055, ELZ-0015056, ELZ-0015057, ELZ-0015058, ELZ-0015059, ELZ-0015060, ELZ-0015061, 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ELZ-77135973, ELZ-77135976, ELZ-77135977, ELZ-77135981, ELZ-77135982, ELZ-77135985, ELZ-77135987, ELZ-77135990, ELZ-77135990, ELZ-77135992, ELZ-77135996, ELZ-77166572, ELZ-77166573, ELZ-77166574, ELZ-77166575, ELZ-77166576, ELZ-77166577, ELZ-77166578, ELZ-77166579, ELZ-77166580, ELZ-77166582, ELZ-77166584, ELZ-77166585, ELZ-77385615, ELZ-77385616, ELZ-77385617, ELZ-77385618, ELZ-77385619, ELZ-77385620, ELZ-77385621, ELZ-77385622, ELZ-77385623, ELZ-77385624, ELZ-77385625, ELZ-77385626, ELZ-77385627, ELZ-77385628, ELZ-77385629, ELZ-77385630, ELZ-77385631, ELZ-77385632, ELZ-77385633, ELZ-77385634, ELZ-77385635, ELZ-77385636, ELZ-77385637, ELZ-77385638, ELZ-77385639, ELZ-77385640, ELZ-77385641, ELZ-77385642, ELZ-77385643, ELZ-77385644, ELZ-77385645, ELZ-77385646, ELZ-77385647, ELZ-77385648, ELZ-77385649, ELZ-77385650, ELZ-77385651, ELZ-77385652, ELZ-77385653, ELZ-77385654, ELZ-77385655, ELZ-77385656, ELZ-77385657, ELZ-77385658, ELZ-77385659, ELZ-77385660, ELZ-77385661, ELZ-77385662, ELZ-77385663, ELZ-77385664, ELZ-77385665, ELZ-77385666, ELZ-77385667, ELZ-77385668, ELZ-77385669, ELZ-77385670, ELZ-77385671, ELZ-77385672, ELZ-77385673, ELZ-77385674, ELZ-77385675, ELZ-77385676, ELZ-77385677, ELZ-77385678, ELZ-77385679, ELZ-77385680, ELZ-77385681, ELZ-77385682, ELZ-77385683, ELZ-77385684, ELZ-77385685, ELZ-77385686, ELZ-77385687, ELZ-77385688, ELZ-77385689, ELZ-77385690, ELZ-77385691, ELZ-77385692, ELZ-77385693, ELZ-77385694, ELZ-77385695, ELZ-77385696, ELZ-77385697, ELZ-77385698, ELZ-77385699, ELZ-77385700, ELZ-77385701, ELZ-77385702, ELZ-77385703, ELZ-77385704, ELZ-77385705, ELZ-77385707, ELZ-77385708, ELZ-77385709, ELZ-77385710, ELZ-77385711, ELZ-77385712, ELZ-77385713, ELZ-77385714, ELZ-77385715, ELZ-77385718, ELZ-77385719, ELZ-77385720, ELZ-77385721, ELZ-77385722, ELZ-77385723, ELZ-77385725, ELZ-77385726, ELZ-77385727, ELZ-77385728, ELZ-77385729, ELZ-77385730, ELZ-77385731, ELZ-77385732, ELZ-77385733, ELZ-77385734, ELZ-77385735, ELZ-77385736, ELZ-77385737, ELZ-77385738, ELZ-77385739, ELZ-77385740, ELZ-77385741, ELZ-77385742, ELZ-77385743, ELZ-77385744, ELZ-77385745, ELZ-77385746, ELZ-77385747, ELZ-77385748, ELZ-77385749, ELZ-77385750, ELZ-77385751, ELZ-77385752, ELZ-77385753, ELZ-77385755, ELZ-77385756, ELZ-77385759, ELZ-77385760, ELZ-77385761, ELZ-77385762, ELZ-77385763, ELZ-77385764, ELZ-77385765, ELZ-77385766, ELZ-77385767, ELZ-77385768, ELZ-77385769, ELZ-77385770, ELZ-77385771, ELZ-77385772, ELZ-77385773, ELZ-77385774, ELZ-77385776, ELZ-77385777, ELZ-77385778, ELZ-77385779, ELZ-77385781, ELZ-77385783, ELZ-77385784, ELZ-77385785, ELZ-77385786, ELZ-77385787, ELZ-77385788, ELZ-77385789, ELZ-77385790, ELZ-77385791, ELZ-77385792, ELZ-77385793, ELZ-77385797, ELZ-77385820, ELZ-77385821, ELZ-77385822, ELZ-77385823, ELZ-77385824, ELZ-77385825, ELZ-77385826, ELZ-77385828, ELZ-77385829, ELZ-77385830, ELZ-77385831, ELZ-77385832, ELZ-77385833, ELZ-77385834, ELZ-77385835, ELZ-77385836, ELZ-77385837, ELZ-77385838, ELZ-77385839, ELZ-77385840, ELZ-77385843, ELZ-77385845, ELZ-77385846, ELZ-77385847, ELZ-77385851, ELZ-77385852, ELZ-77385853, ELZ-77385854, ELZ-77385857, ELZ-77385858, ELZ-77385860, ELZ-77385862, ELZ-77385864, ELZ-77385869, ELZ-77385871, ELZ-77385874, ELZ-77385875, ELZ-77385876, ELZ-77385879, ELZ-77385880, ELZ-77385881, ELZ-77385882, ELZ-77385885, ELZ-77385886, ELZ-77385887, ELZ-77385888, ELZ-77385889, ELZ-77385890, ELZ-77385893, ELZ-77385894, ELZ-77385895, ELZ-77385896, ELZ-77385897, ELZ-77385898, ELZ-77385899, ELZ-77385900, ELZ-77385902, ELZ-77385903, ELZ-77385904, ELZ-77385907, ELZ-77385908, ELZ-77385909, ELZ-77385910, ELZ-77385911, ELZ-77385912, ELZ-77385913, ELZ-77385914, ELZ-77385915, ELZ-77385916, ELZ-77385917, ELZ-77385918, ELZ-77385919, ELZ-77385920, ELZ-77385921, ELZ-77385922, ELZ-77385923, ELZ-77385924, ELZ-77385925, ELZ-77385926, ELZ-77385927, ELZ-77385928, ELZ-77385929, ELZ-77385930, ELZ-77385931, ELZ-77385932, ELZ-77385933, ELZ-77385934, ELZ-77385935, ELZ-77385936, ELZ-77385937, ELZ-77385938, ELZ-77385939, ELZ-77385940, ELZ-77385941, ELZ-77385943, ELZ-77385944, ELZ-77385946, ELZ-77385947, ELZ-77385948, ELZ-77385949, ELZ-77385950, ELZ-77385951, ELZ-77385952, ELZ-77385955, ELZ-77385956, ELZ-77385957, ELZ-77385959, ELZ-77385960, ELZ-77385961, ELZ-77385962, ELZ-77385963, ELZ-77385965, ELZ-77385966, ELZ-77385967, ELZ-77385968, ELZ-77385969, ELZ-77385971, ELZ-77385972, ELZ-77385973, ELZ-77385974, ELZ-77385975, ELZ-77385976, ELZ-77385978, ELZ-77385979, ELZ-77385980, ELZ-77385981, ELZ-77385982, ELZ-77385983, ELZ-77385984, ELZ-77385985, ELZ-77385986, ELZ-77385987, ELZ-77385988, ELZ-77385989, ELZ-77385990, ELZ-77385991, ELZ-77385992, ELZ-77385993, ELZ-77385994, ELZ-77385995, ELZ-77385996, ELZ-77385997, ELZ-77385998, ELZ-77385999, ELZ-77386000, ELZ-77386001, ELZ-77386002, ELZ-77386003, ELZ-77386004, ELZ-77386005, ELZ-77386006, ELZ-77386007, ELZ-77386008, ELZ-77386009, ELZ-77386010, ELZ-77386011, ELZ-77386012, ELZ-77386013, ELZ-77386014, ELZ-77386015, ELZ-77386016, ELZ-77386017, ELZ-77386018, ELZ-77386019, ELZ-77386020, ELZ-77386021, ELZ-77386022, ELZ-77386023, ELZ-77386024, ELZ-77386025, ELZ-77386026, ELZ-77386027, ELZ-77386028, ELZ-77386029, ELZ-77386030, ELZ-77386031, ELZ-77386032, ELZ-77386033, ELZ-77386034, and ELZ-77386035.  Lot/Serial Numbers on the systems for Foreign Consignees:  ELZ-0014568, ELZ-0014569, ELZ-0014571, ELZ-0014572, ELZ-0014573, ELZ-0014575, ELZ-0014576, ELZ-0014578, ELZ-0014579, ELZ-0014582, ELZ-0014584, ELZ-0014588, ELZ-0014589, ELZ-0014602, ELZ-0014624, ELZ-0014627, ELZ-0014628, ELZ-0014643, ELZ-0014644, ELZ-0014646, ELZ-0014649, ELZ-0014650, ELZ-0014651, ELZ-0014652, ELZ-0014655, ELZ-0014659, ELZ-0014660, ELZ-0014661, ELZ-0014721, ELZ-0014722, ELZ-0014725, ELZ-0014728, ELZ-0014730, ELZ-0014732, ELZ-0014734, ELZ-0014739, ELZ-0014741, ELZ-0014743, ELZ-0014746, ELZ-0014747, ELZ-0014748, ELZ-0014749, ELZ-0014751, ELZ-0014753, ELZ-0014757, ELZ-0014761, ELZ-0014763, ELZ-0014769, ELZ-0014777, ELZ-0014778, ELZ-0014779, ELZ-0014784, ELZ-0014789, ELZ-0014792, ELZ-0014794, ELZ-0014796, ELZ-0014797, ELZ-0014798, ELZ-0014799, ELZ-0014801, ELZ-0014802, ELZ-0014803, ELZ-0014804, ELZ-0014807, ELZ-0014808, ELZ-0014809, ELZ-0014811, ELZ-0014812, ELZ-0014813, ELZ-0014814, ELZ-0014815, ELZ-0014818, ELZ-0014821, ELZ-0014822, ELZ-0014825, ELZ-0014826, ELZ-0014829, ELZ-0014830, ELZ-0014831, ELZ-0014832, ELZ-0014835, ELZ-0014838, ELZ-0014840, ELZ-0014841, ELZ-0014843, ELZ-0014844, ELZ-0014845, ELZ-0014847, ELZ-0014848, ELZ-0014849, ELZ-0014851, ELZ-0014856, ELZ-0014862, ELZ-0014870, ELZ-0014884, ELZ-0014889, ELZ-0014897, ELZ-0014898, ELZ-0014899, ELZ-0014901, ELZ-0014903, ELZ-0014904, ELZ-0014907, ELZ-0014908, ELZ-0014909, ELZ-0014911, ELZ-0014912, ELZ-0014918, ELZ-0014919, ELZ-0014921, ELZ-0014923, ELZ-0014928, ELZ-0014939, ELZ-0014946, ELZ-0014948, ELZ-0014952, ELZ-0014962, ELZ-0014963, ELZ-0014966, ELZ-0014967, ELZ-0014970, ELZ-0014971, ELZ-0014978, ELZ-0014980, ELZ-0014984, ELZ-0014988, ELZ-0014990, ELZ-0014991, ELZ-0014993, ELZ-0014997, ELZ-0014998, ELZ-0015003, ELZ-0015004, ELZ-0015041, ELZ-0015072, ELZ-0015079, ELZ-0015086, ELZ-0015092, ELZ-0015106, ELZ-0015108, ELZ-0015109, ELZ-0015110, ELZ-0015111, ELZ-0015112, ELZ-0015115, ELZ-0015116, ELZ-0015117, ELZ-0015124, ELZ-0015137, ELZ-0015141, ELZ-0015142, ELZ-0015143, ELZ-0015147, ELZ-0015148, ELZ-0015149, ELZ-0015151, ELZ-0015153, ELZ-0015156, ELZ-0015160, ELZ-0015162, ELZ-0015171, ELZ-0015172, ELZ-0015175, ELZ-0015176, ELZ-0015177, ELZ-0015178, ELZ-0015180, ELZ-0015182, ELZ-0015183, ELZ-0015185, ELZ-0015186, ELZ-0015190, ELZ-0015191, ELZ-0015192, ELZ-0015193, ELZ-0015195, ELZ-0015196, ELZ-0015198, ELZ-0015202, ELZ-0015211, ELZ-0015254, ELZ-0015258, ELZ-0015259, ELZ-0015260, ELZ-0015261, ELZ-0015263, ELZ-0015269, ELZ-0015270, ELZ-0015272, ELZ-0015275, ELZ-0015278, ELZ-0015283, ELZ-0015287, ELZ-0015289, ELZ-0015290, ELZ-0015313, ELZ-0015314, ELZ-0015324, ELZ-0015325, ELZ-0015329, ELZ-0015356, ELZ-0015417, ELZ-0015421, ELZ-0015423, ELZ-0015424, ELZ-0015431, ELZ-0015433, ELZ-0015440, ELZ-0015477, ELZ-0015478, ELZ-0015481, ELZ-0015483, ELZ-0015484, ELZ-0015487, ELZ-0015491, ELZ-0015492, ELZ-0015493, ELZ-0015494, ELZ-0015497, ELZ-0015498, ELZ-0015499, ELZ-0015500, ELZ-0015502, ELZ-0015504, ELZ-0015505, ELZ-0015507, ELZ-0015508, ELZ-0015512, ELZ-0015513, ELZ-0015514, ELZ-0015516, ELZ-0015517, ELZ-0015518, ELZ-0015519, ELZ-0015520, ELZ-0015521, ELZ-0015522, ELZ-0015524, ELZ-0015527, ELZ-0015528, ELZ-0015530, ELZ-0015531, ELZ-0015532, ELZ-0015533, ELZ-0015534, ELZ-0015535, ELZ-0015548, ELZ-0015557, ELZ-0015563, ELZ-0015565, ELZ-0015569, ELZ-0015595, ELZ-0015596, ELZ-0015607, ELZ-0015610, ELZ-0015623, ELZ-0015636, ELZ-0015637, ELZ-0015638, ELZ-0015639, ELZ-0015640, ELZ-0015641, ELZ-0015642, ELZ-0015643, ELZ-0015644, ELZ-0015645, ELZ-0015652, ELZ-0015653, ELZ-0015695, ELZ-0015721, ELZ-0015729, ELZ-0015730, ELZ-0015733, ELZ-0015734, ELZ-0015735, ELZ-0015757, ELZ-0015761, ELZ-0015766, ELZ-0015767, ELZ-0015768, ELZ-0015769, ELZ-0015774, ELZ-0015779, ELZ-0015780, ELZ-0015796, ELZ-0015797, ELZ-0015894, ELZ-0015942, ELZ-0015977, ELZ-0015981, ELZ-0015989, ELZ-0016012, ELZ-0016014, ELZ-0016015, ELZ-0016016, ELZ-0016020, ELZ-0016021, ELZ-0016022, ELZ-0016023, ELZ-0016047, ELZ-0016050, ELZ-0016066, ELZ-0016068, ELZ-0016069, ELZ-0016070, ELZ-0016072, ELZ-0016073, ELZ-0016075, ELZ-0016079, ELZ-0016080, ELZ-0016084, ELZ-0016085, ELZ-0016086, ELZ-0016088, ELZ-0016102, ELZ-0016104, ELZ-0016109, ELZ-0016113, ELZ-0016119, ELZ-0016130, ELZ-0016133, ELZ-0016195, ELZ-0016199, ELZ-0016208, ELZ-0016238, ELZ-0016252, ELZ-0016258, ELZ-0016268, ELZ-0016270, ELZ-0016274, ELZ-0016277, ELZ-0016278, ELZ-0016279, ELZ-0016281, ELZ-0016284, ELZ-0016285, ELZ-0016304, ELZ-0016308, ELZ-0016321, ELZ-0016323, ELZ-0016327, ELZ-0016331, ELZ-0016334, ELZ-0016354, ELZ-0016363, ELZ-0016368, ELZ-0016369, ELZ-0016371, ELZ-0016374, ELZ-0016378, ELZ-0016380, ELZ-0016382, ELZ-0016383, ELZ-0016385, ELZ-0016389, ELZ-0016390, ELZ-0016391, ELZ-0016394, ELZ-0016395, ELZ-0016396, ELZ-0016397, ELZ-0016400, ELZ-0016401, ELZ-0016403, ELZ-0016405, ELZ-0016406, ELZ-0016409, ELZ-0016410, ELZ-0016411, ELZ-0016412, ELZ-0016415, ELZ-0016417, ELZ-0016420, ELZ-0016422, ELZ-0016427, ELZ-0016432, ELZ-0016462, ELZ-0016489, ELZ-0016504, ELZ-0016513, ELZ-0016516, ELZ-0016520, ELZ-0016521, ELZ-0016523, ELZ-0016527, ELZ-0016531, ELZ-0016535, ELZ-0016539, ELZ-0016542, ELZ-0016563, ELZ-0016576, ELZ-0016585, ELZ-0016586, ELZ-0016587, ELZ-0016592, ELZ-0016593, ELZ-0016594, ELZ-0016595, ELZ-0016596, ELZ-0016597, ELZ-0016599, ELZ-0016600, ELZ-0016602, ELZ-0016604, ELZ-0016606, ELZ-0016613, ELZ-0016614, ELZ-0016615, ELZ-0016616, ELZ-0016619, ELZ-0016627, ELZ-0016635, ELZ-0016636, ELZ-0016642, ELZ-0016643, ELZ-0016651, ELZ-0016655, ELZ-0016656, ELZ-0016667, ELZ-0016678, ELZ-0016679, ELZ-0016680, ELZ-0016691, ELZ-0016695, ELZ-0016696, ELZ-0016712, ELZ-0016744, ELZ-0016746, ELZ-0016757, ELZ-0016787, ELZ-0016800, ELZ-0016808, ELZ-0016818, ELZ-0016833, ELZ-0016837, ELZ-0016840, ELZ-0016841, ELZ-0016856, ELZ-0016874, ELZ-0016887, ELZ-0016890, ELZ-0016904, ELZ-0016908, ELZ-0016913, ELZ-0016918, ELZ-0016922, ELZ-0016926, ELZ-0016928, ELZ-0017493, ELZ-0017497, ELZ-0017503, ELZ-0017506, ELZ-0017508, ELZ-0017518, ELZ-0017532, ELZ-0017543, ELZ-0017600, ELZ-0017608, ELZ-0017610, ELZ-0017614, ELZ-0017616, ELZ-0017624, ELZ-0017627, ELZ-0017631, ELZ-0017675, ELZ-0017685, ELZ-0017688, ELZ-0017693, ELZ-0017694, ELZ-0017697, ELZ-0017698, ELZ-0017701, ELZ-0017710, ELZ-0017711, ELZ-0017712, ELZ-0017713, ELZ-0017714, ELZ-0017715, ELZ-0017716, ELZ-0017717, ELZ-0017718, ELZ-0017719, ELZ-0017721, ELZ-0017722, ELZ-0017727, ELZ-0017728, ELZ-0017731, ELZ-0017732, ELZ-0017734, ELZ-0017741, ELZ-0017745, ELZ-0017746, ELZ-0017749, ELZ-0017757, ELZ-0017761, ELZ-0017762, ELZ-0017765, ELZ-0017766, ELZ-0017775, ELZ-0017776, ELZ-0017806, ELZ-0017812, ELZ-0017818, ELZ-0017822, ELZ-0017844, ELZ-0017858, ELZ-0017873, ELZ-0017874, ELZ-0017883, ELZ-0017884, ELZ-0017888, ELZ-0017889, ELZ-0017892, ELZ-0017894, ELZ-0017900, ELZ-0017902, ELZ-0017903, ELZ-0017904, ELZ-0017905, ELZ-0017906, ELZ-0017907, ELZ-0017908, ELZ-0017909, ELZ-0017911, ELZ-0017913, ELZ-0017915, ELZ-0017919, ELZ-0017923, ELZ-0017932, ELZ-0017933, ELZ-0017934, ELZ-0017937, ELZ-0017940, ELZ-0017941, ELZ-0017943, ELZ-0017946, ELZ-0017947, ELZ-0017952, ELZ-0017954, ELZ-0017955, ELZ-0017958, ELZ-0017961, ELZ-0017963, ELZ-0017965, ELZ-0017966, ELZ-0017967, ELZ-0017970, ELZ-0017972, ELZ-0017977, ELZ-0017980, ELZ-0017981, ELZ-0017983, ELZ-0017987, ELZ-0017998, ELZ-0017999, ELZ-0018001, ELZ-0018008, ELZ-0018012, ELZ-0018013, ELZ-0018014, ELZ-0018018, ELZ-0018024, ELZ-0018028, ELZ-0018029, ELZ-0018032, ELZ-0018034, ELZ-0018035, ELZ-0018039, ELZ-0018041, ELZ-0018047, ELZ-0018049, ELZ-0018050, ELZ-0018053, ELZ-0018061, ELZ-0018063, ELZ-0018064, ELZ-0018074, ELZ-0018076, ELZ-0018077, ELZ-0018080, ELZ-0018083, ELZ-0018086, ELZ-0018088, ELZ-0018089, ELZ-0018094, ELZ-0018097, ELZ-0018100, ELZ-0018103, ELZ-0018107, ELZ-0018108, ELZ-0018111, ELZ-0018118, ELZ-0018129, ELZ-77135651, ELZ-77135654, ELZ-77135655, ELZ-77135657, ELZ-77135660, ELZ-77135666, ELZ-77135668, ELZ-77135670, ELZ-77135672, ELZ-77135679, ELZ-77135681, ELZ-77135684, ELZ-77135686, ELZ-77135687, ELZ-77135688, ELZ-77135689, ELZ-77135690, ELZ-77135691, ELZ-77135693, ELZ-77135694, ELZ-77135695, ELZ-77135697, ELZ-77135698, ELZ-77135699, ELZ-77135701, ELZ-77135702, ELZ-77135703, ELZ-77135704, ELZ-77135705, ELZ-77135728, ELZ-77135729, ELZ-77135730, ELZ-77135731, ELZ-77135732, ELZ-77135733, ELZ-77135734, ELZ-77135735, ELZ-77135737, ELZ-77135738, ELZ-77135739, ELZ-77135740, ELZ-77135741, ELZ-77135742, ELZ-77135743, ELZ-77135744, ELZ-77135745, ELZ-77135746, ELZ-77135747, ELZ-77135748, ELZ-77135749, ELZ-77135752, ELZ-77135824, ELZ-77135831, ELZ-77135832, ELZ-77135833, ELZ-77135834, ELZ-77135835, ELZ-77135836, ELZ-77135843, ELZ-77135844, ELZ-77135845, ELZ-77135846, ELZ-77135849, ELZ-77135878, ELZ-77135879, ELZ-77135880, ELZ-77135891, ELZ-77135903, ELZ-77135904, ELZ-77135923, ELZ-77135927, ELZ-77135928, ELZ-77135968, ELZ-77135971, ELZ-77135974, ELZ-77135975, ELZ-77135979, ELZ-77135980, ELZ-77135984, ELZ-77135986, ELZ-77135991, ELZ-77135993, ELZ-77166581, ELZ-77166583, ELZ-77166586, ELZ-77166587, ELZ-77385706, ELZ-77385716, ELZ-77385754, ELZ-77385757, ELZ-77385758, ELZ-77385780, ELZ-77385794, ELZ-77385795, ELZ-77385796, ELZ-77385798, ELZ-77385799, ELZ-77385800, ELZ-77385801, ELZ-77385802, ELZ-77385803, ELZ-77385804, ELZ-77385805, ELZ-77385806, ELZ-77385807, ELZ-77385808, ELZ-77385809, ELZ-77385810, ELZ-77385811, ELZ-77385812, ELZ-77385813, ELZ-77385814, ELZ-77385815, ELZ-77385816, ELZ-77385817, ELZ-77385818, ELZ-77385841, ELZ-77385842, ELZ-77385844, ELZ-77385848, ELZ-77385849, ELZ-77385865, ELZ-77385866, ELZ-77385867, ELZ-77385868, ELZ-77385870, ELZ-77385872, ELZ-77385873, ELZ-77385883, ELZ-77385884, ELZ-77385891, ELZ-77385942, ELZ-77385945, ELZ-77385953, ELZ-77385954, ELZ-77385958, ELZ-77385964, and ELZ-77385970.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA in the following states: AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY, and including the following countries: AUSTRALIA, AUSTRIA, CANADA, Caribbean, CZECH REPUBLIC, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • Descripción del producto
    Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Medical Flat Panel Display
Device Recall Blease Sirius Anaesthesia Systems
  • Modelo / Serial
    Serial numbers: SIRI-000845, SIRI-000862, SIRI-000869, SIRI-000885, and SIRI-000898.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US in the states of LA and SD, and internationally by Spacelabs Healthcare, Ltd in the countries of China, Czech Republic, Hong Kong, India, Poland, Saudi Arabia, Singapore, and the United Kingdom.
  • Descripción del producto
    Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously.. || The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018".
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Blease Sirius Anaesthesia Systems
Device Recall BleaseSirius Anaesthesia Machine
  • Modelo / Serial
    Serial numbers: DOMESTIC - siri-001852, siri-002292, SIRI-002081, SIRI-002082, SIRI-002085, SIRI-002089, SIRI-002091, SIRI-002097, SIRI-002099, SIRI-002101, SIRI-002102, SIRI-001851, SIRI-001818, SIRI-001819, SIRI-001821, SIRI-001822, SIRI-001823, SIRI-001824, SIRI-001825, SIRI-001826, SIRI-001827, SIRI-001828, SIRI-001829, SIRI-002106, and SIRI-002108.   INTERNATIONAL - siri-001861, siri-001853, siri-001855, siri-001857, SIRI-001905, SIRI-002363, SIRI-001948, SIRI-001949, SIRI-001950, SIRI-001951, SIRI-001952, SIRI-001846, SIRI-001847, SIRI-001848, SIRI-001849, SIRI-001921, SIRI-001961, SIRI-001963, SIRI-001964, siri-002139, SIRI-002162, SIRI-002298, SIRI-002349, SIRI-002354, SIRI-001611, SIRI-001612, SIRI-001614, SIRI-001615, SIRI-001616, SIRI-001617, SIRI-002157, siri-002135, SIRI-2302, siri-001903, siri-001904, siri-001911, SIRI-002041, SIRI-001858, SIRI -002150, SIRI-002156, siri-002166, siri-002168, siri-002169, siri-002171, siri-002201, SIRI-001854, SIRI-001785, SIRI-001786, SIRI-001954, SIRI-001850, SIRI-001862, SIRI-002159, SIRI-002304, SIRI-002315, and SIRI-002224.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of IA, GA, LA, NC, TN, and TX and countries of AUSTRALIA, CHILE, CHINA, INDIA, ITALY, PHILIPPINES, MEXICO, POLAND, SINGAPORE, THAILAND, TURKEY, UNITED KINGDOM, and VENEZUELA.
  • Descripción del producto
    BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England || Intended for use in the hospital environment and operating room.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BleaseSirius Anaesthesia Machine
Device Recall Spacelabs Smart Disclosure System, Model 92810
  • Modelo / Serial
    ICS G2 Smart Disclosure Model 92810, Version 4.03.  There are no serial numbers.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.
  • Descripción del producto
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. || The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. || The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. || Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. || The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Smart Disclosure System, Model 92810
Device Recall Integrated Module Housing
  • Modelo / Serial
    Domestic - 1493-000275, 1493-000276, 1493-000277, 1493-002469, 1493-002616, 1493-003358, 1493-003359, 1493-003667, 1493-003668, 1493-003669, 1493-003670, 1493-003671, 1493-003672, 1493-003673, 1493-003674, 1493-003675, 1493-003676, 1493-003677, 1493-003678, 1493-003679, 1493-003680, 1493-003681, 1493-003682, 1493-003683, 1493-003684, 1493-003685, 1493-003686, 1493-003687, 1493-003688, 1493-003693, 1493-003694, 1493-003695, 1493-003696, 1493-003697, 1493-003879, 1493-003880, 1493-003881, 1493-003882, 1493-003883, 1493-003884, 1493-003885, 1493-003886, 1493-003887, 1493-003888, 1493-003889, 1493-003890, 1493-003891, 1493-003892, 1493-003893, 1493-003894, 1493-003895, 1493-003896, 1493-003897, 1493-003898, 1493-003899, 1493-003900, 1493-003901, 1493-003902, 1493-003903, 1493-003904, 1493-003905, 1493-003906, 1493-003907, 1493-003908, 1493-003909, 1493-003914, 1493-003915, 1493-003916, 1493-003917, 1493-003918, 1493-003919, 1493-003920, 1493-003921, 1493-003922, 1493-003923, 1493-003924, 1493-003925, 1493-003926, 1493-003927, 1493-003928, 1493-003929, 1493-003930, 1493-003931, 1493-003932, 1493-003933, 1493-003934, 1493-003935, 1493-003936, 1493-003937, 1493-003938, 1493-003939, 1493-003940, 1493-003941, 1493-003942, 1493-003943, 1493-003944, 1493-003945, 1493-003957, 1493-003958, 1493-003959, 1493-003960, 1493-003961, 1493-003962, 1493-003963, 1493-003964, 1493-003965, 1493-003985, 1493-004007, 1493-004011, 1493-004023, 1493-004026, 1493-004027, 1493-004028, 1493-004029, 1493-004030, 1493-004031, 1493-004032, 1493-004033, 1493-004034, 1493-004043, 1493-004044, 1493-004047, 1493-004048, 1493-004050, 1493-004051, 1493-004052, 1493-004053, 1493-004054, 1493-004055, 1493-004056, 1493-004058, 1493-004060, 1493-004064, 1493-004067, 1493-004068, 1493-004069, 1493-004070, 1493-004071, 1493-004075, 1493-004084, 1493-004085, 1493-004086, 1493-004106, 1493-004112, 1493-004113, 1493-004114, 1493-004115, 1493-004116, 1493-004117, 1493-004118, 1493-004119, 1493-004120, 1493-004121, 1493-004122, 1493-004123, 1493-004124, 1493-004125, 1493-004126, 1493-004127, 1493-004128, 1493-004130, 1493-004158, 1493-004159, 1493-004160, 1493-004161, 1493-004162, 1493-004163, 1493-004164, 1493-004172, 1493-004173, 1493-004174, 1493-004175, 1493-004176, 1493-004177, 1493-004178, 1493-004179, 1493-004180, 1493-004181, 1493-004182, 1493-004183, 1493-004184, 1493-004185, 1493-004205, 1493-004206, 1493-004207, 1493-004208, 1493-004209, 1493-004210, 1493-004211, 1493-004212, 1493-004214, 1493-004215, 1493-004216, 1493-004217, 1493-004218, 1493-004219, 1493-004220, 1493-004221, 1493-004222, 1493-004223, 1493-004224, 1493-004225, 1493-004226, 1493-004227, 1493-004228, 1493-004229, 1493-004230, 1493-004231, 1493-004232, 1493-004233, 1493-004234, 1493-004235, 1493-004236, 1493-004237, 1493-004238, 1493-004239, 1493-004240, 1493-004241, 1493-004242, 1493-004243, 1493-004256, 1493-004257, 1493-004258, 1493-004259, 1493-004260, 1493-004261, 1493-004262, 1493-004263, 1493-004264, 1493-004265, 1493-004266, 1493-004267, 1493-004268, 1493-004269, 1493-004270, 1493-004271, 1493-004272, 1493-004273, 1493-004274, 1493-004275, 1493-004276, 1493-004277, 1493-004278, 1493-004279, 1493-004280, 1493-004281, 1493-004282, 1493-004283, 1493-004284, 1493-004285, 1493-004286, 1493-004287, 1493-004288, 1493-004289, 1493-004290, 1493-004291, 1493-004292, 1493-004293, 1493-004294, 1493-004295, 1493-004296, 1493-004297, 1493-004298, 1493-004299, 1493-004301, 1493-004302, 1493-004306, 1493-004307, 1493-004308, 1493-004309, 1493-004310, 1493-004311, 1493-004312, 1493-004313, 1493-004314, 1493-004315, 1493-004316, 1493-004317, 1493-004318, 1493-004319, 1493-004320, 1493-004321, 1493-004322, 1493-004323, 1493-004324, 1493-004325, 1493-004326, 1493-004327, 1493-004328, 1493-004329, 1493-004330, 1493-004331, 1493-004332, 1493-004333, 1493-004334, 1493-004335, 1493-004336, 1493-004337, 1493-004338, 1493-004339, 1493-004340, 1493-004341, 1493-004342, 1493-004343, 1493-004344, 1493-004345, 1493-004346, 1493-004347, 1493-004348, 1493-004349, 1493-004350, 1493-004351, 1493-004352, 1493-004353, 1493-004354, 1493-004355, 1493-004356, 1493-004357, 1493-004358, 1493-004359, 1493-004360, 1493-004361, 1493-004362, 1493-004363, 1493-004364, 1493-004365, 1493-004366, 1493-004367, 1493-004368, 1493-004369, 1493-004370, 1493-004371, 1493-004372, 1493-004373, 1493-004374, 1493-004375, 1493-004376, 1493-004377, 1493-004378, 1493-004379, 1493-004380, 1493-004381, 1493-004382, 1493-004383, 1493-004384, 1493-004385, 1493-004405, 1493-004406, 1493-004407, and 1493-004408.   International - 1493-002941, 1493-003666, 1493-003689, 1493-003690, 1493-003691, 1493-003692, 1493-003910, 1493-003911, 1493-003912, 1493-003913, 1493-003946, 1493-003947, 1493-003948, 1493-003949, 1493-003950, 1493-003951, 1493-003952, 1493-003953, 1493-003954, 1493-003955, 1493-003956, 1493-003966, 1493-003967, 1493-003968, 1493-003969, 1493-003970, 1493-003971, 1493-003972, 1493-003973, 1493-003974, 1493-003975, 1493-003976, 1493-003977, 1493-003978, 1493-003979, 1493-003980, 1493-003981, 1493-003982, 1493-003983, 1493-003984, 1493-003986, 1493-003987, 1493-003988, 1493-003989, 1493-003990, 1493-003991, 1493-003992, 1493-003993, 1493-003994, 1493-003995, 1493-003996, 1493-003997, 1493-003998, 1493-003999, 1493-004000, 1493-004001, 1493-004002, 1493-004003, 1493-004004, 1493-004005, 1493-004008, 1493-004009, 1493-004010, 1493-004012, 1493-004013, 1493-004014, 1493-004015, 1493-004016, 1493-004017, 1493-004018, 1493-004019, 1493-004020, 1493-004021, 1493-004022, 1493-004024, 1493-004025, 1493-004035, 1493-004036, 1493-004037, 1493-004038, 1493-004039, 1493-004040, 1493-004041, 1493-004042, 1493-004045, 1493-004046, 1493-004065, 1493-004066, 1493-004072, 1493-004073, 1493-004074, 1493-004076, 1493-004078, 1493-004079, 1493-004080, 1493-004081, 1493-004083, 1493-004087, 1493-004088, 1493-004089, 1493-004090, 1493-004091, 1493-004092, 1493-004093, 1493-004094, 1493-004095, 1493-004096, 1493-004097, 1493-004098, 1493-004099, 1493-004100, 1493-004101, 1493-004102, 1493-004103, 1493-004104, 1493-004105, 1493-004107, 1493-004108, 1493-004109, 1493-004110, 1493-004111, 1493-004129, 1493-004131, 1493-004132, 1493-004133, 1493-004134, 1493-004135, 1493-004136, 1493-004137, 1493-004138, 1493-004139, 1493-004140, 1493-004141, 1493-004142, 1493-004143, 1493-004144, 1493-004145, 1493-004146, 1493-004147, 1493-004148, 1493-004149, 1493-004150, 1493-004151, 1493-004152, 1493-004153, 1493-004154, 1493-004155, 1493-004165, 1493-004166, 1493-004167, 1493-004168, 1493-004169, 1493-004170, 1493-004171, 1493-004186, 1493-004187, 1493-004188, 1493-004189, 1493-004190, 1493-004191, 1493-004192, 1493-004193, 1493-004194, 1493-004195, 1493-004196, 1493-004197, 1493-004198, 1493-004199, 1493-004200, 1493-004201, 1493-004202, 1493-004203, 1493-004204, 1493-004300, 1493-004304, 1493-004305, and 670-1350-00.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Ultraview SL 91493 Integrated Module Housing. || PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Integrated Module Housing
Device Recall Spacelabs Medical Xprezzon Bedside Monitor, Model 91393
  • Modelo / Serial
    040-1632-00; 1393-000013; 1393-000039; 1393-000040; 1393-000041; 1393-000341; 1393-000382; 1393-000383; 1393-000384; 1393-000385; 1393-000386; 1393-000387; 1393-000388; 1393-000808; 1393-000831; 1393-001374; 1393-001375; 1393-001453; 1393-001990; 1393-001991; and 1393-001992.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
  • Descripción del producto
    Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. || The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Medical Xprezzon Bedside Monitor, Model 91393
BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation
  • Modelo / Serial
    SERIAL NUMBERS IN THE US:  ABSO-001754, ABSO-004081, ABSO-100111, ABSO-100112, ABSO-100113, ABSO-100114, ABSO-100117, ABSO-100120, ABSO-100121, ABSO-100122, ABSO-100123, ABSO-100124, ABSO-100125, ABSO-100126, ABSO-100127, ABSO-100128, ABSO-100132, ABSO-100134, and ABSO-100135.   SERIAL NUMBERS INTERNATIONAL:  ABSO-100098, ABSO-100099, abso-100100, ABSO-100101, abso-100102, ABSO-100103, abso-100104, abso-100105, abso-100106, ABSO-100107, ABSO-100108, ABSO-100109, ABSO-100110, ABSO-100129, ABSO-100130, ABSO-100131, ABSO-100136, AND ABSO-100137.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
  • Descripción del producto
    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. || BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation
Spacelabs Healthcare CardioExpress SL6 ECG cable
  • Modelo / Serial
    Serial numbers:  98400-SL6-AHA1030508, 98400-SL6-AHA1030509, 98400-SL6-AHA1030510, 98400-SL6-AHA1030511, 98400-SL6-AHA1030512, 98400-SL6-AHA1030513, 98400-SL6-AHA1030514, 98400-SL6-AHA1030515, 98400-SL6-AHA1030516, 98400-SL6-AHA1030517, 98400-SL6-AHA1030518, 98400-SL6-AHA1030519, 98400-SL6-AHA1030520, 98400-SL6-AHA1030521, 98400-SL6-AHA1030522.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. || The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Spacelabs Healthcare CardioExpress SL6 ECG cable
Ambulatory Blood Pressure (ABP) Monitor
  • Modelo / Serial
    Serial Numbers: 217A-000001, 217A-000013, 217A-000017, 217A-000018, 217A-000019, 217A-000020, 217A-000021, 217A-000022, 217A-000026, 217A-000027, 217A-000028, 217A-000029, 217A-000032, 217A-000033, 217A-000034, 217A-000035, 217A-000036, 217A-000037, 217A-000038, 217A-000039, 217A-000040, 217A-000041, 217A-000042, 217A-000043, 217A-000044, 217A-000045, 217A-000046, 217A-000047, 217A-000048, 217A-000049, 217A-000050, 217A-000051, 217A-000052, 217A-000055, 217A-000056, 217A-000057, 217A-000058, 217A-000059, 217A-000060, 217A-000066, 217A-000068, 217A-000069, 217A-000070, 217A-000071, 217A-000072, 217A-000073, 217A-000074, 217A-000075, 217A-000076, 217A-000077, 217A-000078, 217A-000079, 217A-000080, 217A-000081, 217A-000082, 217A-000083, 217A-000084, 217A-000085, 217A-000086, 217A-000087, 217A-000088, 217A-000089, 217A-000090, 217A-000091, 217A-000092, 217A-000093, 217A-000094, 217A-000095, 217A-000096, 217A-000103, 217A-000104, 217A-000105, 217A-000106, 217A-000107, 217A-000108, 217A-000109, 217A-000110, 217A-000111, 217A-000112, 217A-000113, 217A-000114, 217A-000115, 217A-000116, 217A-000117, 217A-000118, 217A-000119, 217A-000120, 217A-000121, 217A-000122, 217A-000123, 217A-000124, 217A-000125, 217A-000126, 217A-000127, 217A-000128, 217A-000129, 217A-000130, 217A-000131, 217A-000132, 217A-000133, 217A-000134, 217A-000135, 217A-000136, 217A-000137, 217A-000138, 217A-000139, 217A-000140, 217A-000141, 217A-000142, 217A-000143, 217A-000144, 217A-000145, 217A-000146, 217A-000147, 217A-000148, 217A-000149, 217A-000150, 217A-000151, 217A-000152, 217A-000153, 217A-000154, 217A-000155, 217A-000156, 217A-000157, 217A-000158, 217A-000159, 217A-000160, 217A-000161, 217A-000162, 217A-000163, 217A-000164, 217A-000165, 217A-000166, 217A-000167, 217A-000168, 217A-000169, 217A-000170, 217A-000171, 217A-000172, 217A-000173, 217A-000174, 217A-000175, 217A-000176, 217A-000177, 217A-000178, 217A-000179, 217A-000180, 217A-000181, 217A-000182, 217A-000183, 217A-000184, 217A-000185, 217A-000186, 217A-000187, 217A-000188, 217A-000189, 217A-000190, 217A-000191, 217A-000192, 217A-000193, 217A-000194, 217A-000195, 217A-000196, 217A-000197, 217A-000198, 217A-000199, 217A-000200, 217A-000201, 217A-000202, 217A-000203, 217A-000204, 217A-000205, 217A-000207, 217A-000208, 217A-000209, 217A-000210, 217A-000211, 217A-000212, 217A-000213, 217A-000214, 217A-000215, 217A-000216, 217A-000217, 217A-000218, 217A-000219, 217A-000220, 217A-000221, 217A-000222, 217A-000223, 217A-000224, 217A-000225, 217A-000226, 217A-000227, 217A-000228, 217A-000229, 217A-000230, 217A-000231, 217A-000232, 217A-000233, 217A-000234, 217A-000235, 217A-000236, 217A-000237, 217A-000238, 217A-000239, 217A-000240, 217A-000241, 217A-000242, 217A-000243, 217A-000244, 217A-000245, 217A-000246, 217A-000247, 217A-000248, 217A-000249, 217A-000250, 217A-000251, 217A-000252, 217A-000253, 217A-000254, 217A-000255, 217A-000256, 217A-000257, 217A-000258, 217A-000259, 217A-000260, 217A-000261, 217A-000262, 217A-000263, 217A-000264, 217A-000265, 217A-000266, 217A-000267, 217A-000268, 217A-000269, 217A-000270, 217A-000271, 217A-000272, 217A-000273, 217A-000274, 217A-000275, 217A-000276, 217A-000277, 217A-000278, 217A-000279, 217A-000280, 217A-000281, 217A-000282, 217A-000283, 217A-000284, 217A-000285, 217A-000286, 217A-000287, 217A-000288, 217A-000289, 217A-000290, 217A-000291, 217A-000292, 217A-000293, 217A-000294, 217A-000295, 217A-000296, 217A-000297, 217A-000298, 217A-000299, 217A-000300, 217A-000301, 217A-000302, 217A-000303, 217A-000304, 217A-000305, 217A-000306, 217A-000307, 217A-000308, 217A-000309, 217A-000310, 217A-000311, 217A-000312, 217A-000313, 217A-000314, 217A-000315, 217A-000316, 217A-000317, 217A-000318, 217A-000319, 217A-000320, 217A-000321, 217A-000322, 217A-000323, 217A-000324, 217A-000325, 217A-000326, 217A-000327, 217A-000328, 217A-000329, 217A-000330, 217A-000331, 217A-000332, 217A-000333, 217A-000334, 217A-000335, 217A-000336, 217A-000337, 217A-000338, 217A-000339, 217A-000340, 217A-000341, 217A-000343, 217A-000344, 217A-000345, 217A-000346, 217A-000347, 217A-000348, 217A-000349, 217A-000350, 217A-000351, 217A-000352, 217A-000353, 217A-000354, 217A-000355, 217A-000356, 217A-000357, 217A-000358, 217A-000359, 217A-000360, 217A-000361, 217A-000362, 217A-000363, 217A-000364, 217A-000365, 217A-000366, 217A-000367, 217A-000368, 217A-000369, 217A-000370, 217A-000371, 217A-000372, 217A-000373, 217A-000374, 217A-000375, 217A-000376, 217A-000377, 217A-000378, 217A-000379, 217A-000380, 217A-000381, 217A-000382, 217A-000383, 217A-000384, 217A-000385, 217A-000386, 217A-000387, 217A-000388, 217A-000389, 217A-000390, 217A-000391, 217A-000392, 217A-000393, 217A-000394, 217A-000395, 217A-000396, 217A-000397, 217A-000398, 217A-000399, 217A-000400, 217A-000401, 217A-000402, 217A-000403, 217A-000404, 217A-000405, 217A-000406, 217A-000407, 217A-000408, 217A-000409, 217A-000410, 217A-000411, 217A-000412, 217A-000413, 217A-000414, 217A-000415, 217A-000416, 217A-000417, 217A-000418, 217A-000419, 217A-000421, 217A-000422, 217A-000423, 217A-000424, 217A-000425, 217A-000427, 217A-000428, 217A-000430, 217A-000431, 217A-000433, 217A-000435, 217A-000437, 217A-000438, 217A-000439, 217A-000440, 217A-000441, 217A-000442, 217A-000443, 217A-000444, 217A-000446, 217A-000447, 217A-000448, 217A-000449, 217A-000450, 217A-000452, 217A-000453, 217A-000454, 217A-000455, 217A-000456, 217A-000457, 217A-000458, 217A-000459, 217A-000460, 217A-000461, 217A-000465, 217A-000467, 217A-000469, 217A-000470, 217A-000471, 217A-000472, 217A-000473, 217A-000474, 217A-000475, 217A-000476, 217A-000477, 217A-000478, 217A-000480, 217A-000481, 217A-000482, 217A-000484, 217A-000485, 217A-000486, 217A-000487, 217A-000488, 217A-000489, 217A-000490, 217A-000491, 217A-000492, 217A-000493, 217A-000494, 217A-000495, 217A-000496, 217A-000498, 217A-000499, 217A-000500, 217A-000501, 217A-000502, 217A-000503, 217A-000505, 217A-000506, 217A-000507, 217A-000508, 217A-000509, 217A-000510, 217A-000511, 217A-000512, 217A-000513, 217A-000514, 217A-000515, 217A-000516, 217A-000517, 217A-000518, 217A-000519, 217A-000520, 217A-000521, 217A-000522, 217A-000524, 217A-000525, 217A-000526, 217A-000527, 217A-000528, 217A-000529, 217A-000532, 217A-000534, 217A-000535, 217A-000536, 217A-000538, 217A-000539, 217A-000540, 217A-000541, 217A-000542, 217A-000543, 217A-000544, 217A-000545, 217A-000546, 217A-000547, 217A-000548, 217A-000550, 217A-000551, 217A-000552, 217A-000553, 217A-000554, 217A-000555, 217A-000556, 217A-000557, 217A-000558, 217A-000559, 217A-000560, 217A-000561, 217A-000562, 217A-000563, 217A-000564, 217A-000565, 217A-000566, 217A-000567, 217A-000568, 217A-000570, 217A-000571, 217A-000572, 217A-000573, 217A-000574, 217A-000584, 217A-000585, 217A-000586, 217A-000587, 217A-000588, 217A-000589, 217A-000590, 217A-000591, 217A-000592, 217A-000593, 217A-000594, 217A-000595, 217A-000596, 217A-000597, 217A-000598, 217A-000599, 217A-000600, 217A-000601, 217A-000602, 217A-000603, 217A-000604, 217A-000605, 217A-000606, 217A-000608, 217A-000609, 217A-000610, 217A-000611, 217A-000612, 217A-000614, 217A-000615, 217A-000616, 217A-000617, 217A-000618, 217A-000619, 217A-000620, 217A-000621, 217A-000622, 217A-000623, 217A-000624, 217A-000626, 217A-000627, 217A-000628, 217A-000629, 217A-000630, 217A-000631, 217A-000632, 217A-000633, 217A-000634, 217A-000635, 217A-000636, 217A-000637, 217A-000638, 217A-000639, 217A-000640, 217A-000641, 217A-000642, 217A-000643, 217A-000644, 217A-000645, 217A-000646, 217A-000647, 217A-000648, 217A-000649, 217A-000650, 217A-000651, 217A-000652, 217A-000654, 217A-000655, 217A-000656, 217A-000657, 217A-000658, 217A-000659, 217A-000660, 217A-000661, 217A-000662, 217A-000663, 217A-000664, 217A-000665, 217A-000666, 217A-000667, 217A-000668, 217A-000669, 217A-000670, 217A-000671, 217A-000672, 217A-000673, 217A-000674, 217A-000675, 217A-000676, 217A-000677, 217A-000678, 217A-000679, 217A-000680, 217A-000681, 217A-000682, 217A-000683, 217A-000684, 217A-000685, 217A-000686, 217A-000687, 217A-000688, 217A-000691, 217A-000692, 217A-000693, 217A-000694, 217A-000695, 217A-000696, 217A-000697, 217A-000698, 217A-000699, 217A-000700, 217A-000701, 217A-000702, 217A-000703, 217A-000704, 217A-000705, 217A-000706, 217A-000707, 217A-000709, 217A-000710, 217A-000712, 217A-000713, 217A-000715, 217A-000716, 217A-000717, 217A-000718, 217A-000719, 217A-000720, 217A-000721, 217A-000722, 217A-000723, 217A-000724, 217A-000725, 217A-000726, 217A-000727, 217A-000728, 217A-000729, 217A-000730, 217A-000731, 217A-000732, 217A-000733, 217A-000734, 217A-000735, 217A-000736, 217A-000737, 217A-000738, 217A-000739, 217A-000740, 217A-000741, 217A-000742, 217A-000743, 217A-000744, 217A-000745, 217A-000746, 217A-000747, 217A-000748, 217A-000749, 217A-000750, 217A-000751, 217A-000752, 217A-000753, 217A-000754, 217A-000755, 217A-000756, 217A-000757, 217A-000758, 217A-000759, 217A-000760, 217A-000761, 217A-000762, 217A-000763, 217A-000764, 217A-000765, 217A-000766, 217A-000767, 217A-000768, 217A-000769, 217A-000770, 217A-000771, 217A-000772, 217A-000773, 217A-000774, 217A-000775, 217A-000776, 217A-000777, 217A-000778, 217A-000779, 217A-000780, 217A-000781, 217A-000782, 217A-000783, 217A-000784, 217A-000785, 217A-000786, 217A-000787, 217A-000789, 217A-000790, 217A-000791, 217A-000793, 217A-000794, 217A-000796, 217A-000797, 217A-000798, 217A-000799, 217A-000800, 217A-000801, 217A-000802, 217A-000803, 217A-000804, 217A-000805, 217A-000806, 217A-000807, 217A-000809, 217A-000810, 217A-000811, 217A-000812, 217A-000814, 217A-000815, 217A-000816, 217A-000817, 217A-000818, 217A-000819, 217A-000820, 217A-000821, 217A-000822, 217A-000823, 217A-000824, 217A-000825, 217A-000827, 217A-000828, 217A-000829, 217A-000830, 217A-000831, 217A-000832, 217A-000833, 217A-000834, 217A-000835, 217A-000836, 217A-000837, 217A-000838, 217A-000839, 217A-000840, 217A-000842, 217A-000843, 217A-000844, 217A-000845, 217A-000846, 217A-000847, 217A-000848, 217A-000849, 217A-000861, 217A-000863, 217A-000864, 217A-000865, 217A-000866, 217A-000867, 217A-000869, 217A-000870, 217A-000871, 217A-000872, 217A-000873, 217A-000874, 217A-000875, 217A-000876, 217A-000877, 217A-000878, 217A-000879, 217A-000880, 217A-000902, and 217A-000904.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. || The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Ambulatory Blood Pressure (ABP) Monitor
Device Recall Arkon Anesthesia Delivery System
  • Modelo / Serial
    SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US:  ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of North Carolina and South Carolina
  • Descripción del producto
    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Arkon Anesthesia Delivery System
Device Recall Spacelabs ARKON Anesthesia Workstation
  • Modelo / Serial
    ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
  • Descripción del producto
    Spacelabs ARKON Anesthesia Workstation. || Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs ARKON Anesthesia Workstation
Device Recall BleaseFocus Anesthesia Workstations
  • Modelo / Serial
    serial numbers:  ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087.   Firm added ABSO 004581 - which was inSpacelaabs inventory, in transit to a Field Service Engineer, at the time the recall was initiated. the nonconforming absorber has been replaced with a conforming part and this absober serial number was added to the US Spacelabs Recall tracking.  Five incorrect serialnumbers were included in the original serial numbers provided to FDA. This was a result of a data entry error. An updated US and Rest of the World customer/Serial number was provided to FDA 3/25/2013. The correction to the Rest of the World report is as follows: Incorrect SN Reported to FDA Correct, Nonconforming SN ABSO 005883 ABSO-004514 ABSO 005884 ABSO-004515 ABSO 005885 ABSO-004516 ABSO 005886 ABSO-004517 ABSO 005887 ABSO-004518
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
  • Descripción del producto
    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. || Anesthesia workstation for use in the hospital environment and locations not requiring portability.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BleaseFocus Anesthesia Workstations
Device Recall BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators
  • Modelo / Serial
    Serial numbers for three workstations in the US:  focu-101917; focu-101909; and focu-101881.  Serial numbers for BleaseFocus workstations in other countries:  FOCO-100076, FOCO-100077, FOCO-100078, FOCO-100079, FOCO-100080, FOCO-100081, FOCU-000353, FOCU-000354, FOCU-000355, FOCU-000356, FOCU-000357, FOCU-000364, FOCU-000365, FOCU-000405, FOCU-000406, FOCU-000407, FOCU-000408, FOCU-000409, FOCU-000410, FOCU-000411, FOCU-000412, FOCU-000413, FOCU-000414, FOCU-000415, FOCU-000416, FOCU-000417, FOCU-000418, FOCU-000419, FOCU-000420, FOCU-000421, FOCU-000422, FOCU-000423, FOCU-000424, FOCU-000425, focu-000454, FOCU-000455, FOCU-000456, FOCU-000457, FOCU-000458, FOCU-000459, FOCU-000460, FOCU-000461, FOCU-000462, FOCU-000463, focu-000464, FOCU-000465, FOCU-000466, FOCU-000467, FOCU-000468, FOCU-000469, FOCU-000470, FOCU-000471, FOCU-000472, FOCU-000473, FOCU-000474, FOCU-000475, FOCU-000476, FOCU-000477, FOCU-000478, FOCU-000479, FOCU-000480, FOCU-000481, FOCU-000482, FOCU-000483, FOCU-000484, FOCU-000485, FOCU-000486, FOCU-000487, FOCU-000488, FOCU-000489, FOCU-000490, FOCU-000491, FOCU-000492, FOCU-000493, FOCU-000494, FOCU-000495, FOCU-000496, FOCU-000497, FOCU-000498, FOCU-000499, FOCU-000500, FOCU-000501, FOCU-000502, FOCU-000503, FOCU-000504, FOCU-000505, FOCU-000506, FOCU-000507, FOCU-000508, FOCU-000509, FOCU-000510, FOCU-000511, FOCU-000512, FOCU-000513, FOCU-000514, FOCU-000515, FOCU-000516, FOCU-000517, FOCU-000518, FOCU-000519, FOCU-000520, FOCU-000521, FOCU-000522, FOCU-000523, FOCU-000524, FOCU-000525, FOCU-000526, FOCU-000527, FOCU-000528, FOCU-000529, FOCU-000530, FOCU-000531, FOCU-000532, FOCU-000533, FOCU-000534, FOCU-000535, FOCU-000536, FOCU-000537, FOCU-000538, FOCU-000539, FOCU-000540, FOCU-000541, FOCU-000542, FOCU-000543, FOCU-000544, FOCU-000545, FOCU-000546, FOCU-000547, FOCU-000548, FOCU-000549, FOCU-000550, FOCU-000551, FOCU-000552, FOCU-000553, FOCU-000554, FOCU-000555, FOCU-000556, FOCU-000557, FOCU-000558, FOCU-000562, FOCU-000565, FOCU-000566, FOCU-000567, FOCU-000568, FOCU-000569, FOCU-000570, FOCU-000571, FOCU-000572, FOCU-000573, FOCU-000574, FOCU-000575, FOCU-000576, FOCU-000577, FOCU-000578, focu-000579, focu-000580, FOCU-000581, FOCU-000582, FOCU-000583, FOCU-000584, FOCU-000585, FOCU-000586, FOCU-000587, FOCU-000588, FOCU-000589, FOCU-000590, FOCU-000591, FOCU-000592, FOCU-000593, FOCU-000594, FOCU-000595, FOCU-000596, FOCU-000597, FOCU-000598, FOCU-000599, FOCU-000600, FOCU-000601, FOCU-000602, FOCU-000603, FOCU-000604, FOCU-000605, FOCU-000606, FOCU-000607, FOCU-000608, FOCU-000609, FOCU-000610, FOCU-000611, FOCU-000612, FOCU-000613, FOCU-000614, FOCU-000615, FOCU-000616, FOCU-000617, FOCU-000618, FOCU-000619, FOCU-000620, FOCU-000621, FOCU-000622, FOCU-000623, focu-000624, FOCU-000625, focu-000626, FOCU-000627, FOCU-000628, FOCU-000629, FOCU-000630, FOCU-000631, FOCU-000632, FOCU-000633, FOCU-000634, FOCU-000635, FOCU-000636, FOCU-000637, FOCU-000638, FOCU-000639, FOCU-000640, FOCU-000641, FOCU-000642, FOCU-000643, FOCU-000644, focu-000645, focu-000646, FOCU-000647, focu-000648, focu-000649, FOCU-000650, FOCU-000651, FOCU-000652, FOCU-000653, FOCU-000654, FOCU-000655, FOCU-000656, FOCU-000657, FOCU-000658, FOCU-000659, FOCU-000660, FOCU-000661, FOCU-000662, FOCU-000663, FOCU-000664, FOCU-000665, FOCU-000666, FOCU-000667, FOCU-000668, FOCU-000669, FOCU-000670, FOCU-000671, FOCU-000672, FOCU-000673, FOCU-000674, FOCU-000675, FOCU-000676, FOCU-000677, FOCU-000678, FOCU-000679, FOCU-000680, focu-000681, focu-000682, focu-000683, focu-000684, focu-000685, focu-000686, focu-000687, focu-000688, focu-000689, focu-000690, FOCU-000691, FOCU-000692, FOCU-000693, FOCU-000694, FOCU-000695, FOCU-000696, focu-000697, FOCU-000698, FOCU-000699, FOCU-000700, FOCU-000701, FOCU-000702, FOCU-000703, FOCU-000704, FOCU-000705, FOCU-000706, FOCU-000707, FOCU-000708, FOCU-000709, FOCU-000710, FOCU-000711, FOCU-000712, FOCU-000713, FOCU-000714, FOCU-000715, FOCU-000716, FOCU-000717, FOCU-000718, FOCU-000719, FOCU-000720, FOCU-000721, FOCU-000722, FOCU-000723, FOCU-000724, FOCU-000725, FOCU-000726, FOCU-000727, FOCU-000728, FOCU-000729, focu-000730, focu-000731, focu-000732, FOCU-000733, FOCU-000734, FOCU-000735, FOCU-000736, FOCU-000737, focu-000738, FOCU-000739, focu-000740, FOCU-000741, FOCU-000742, FOCU-000743, FOCU-000750, FOCU-000751, FOCU-000754, FOCU-000755, focu-000756, focu-000757, focu-000758, focu-000759, focu-000760, focu-000761, FOCU-000762, FOCU-000763, FOCU-000764, FOCU-000765, FOCU-000766, FOCU-000767, FOCU-000768, FOCU-000769, FOCU-000770, FOCU-000771, FOCU-000772, FOCU-000773, FOCU-000774, FOCU-000775, FOCU-000776, FOCU-000777, FOCU-000778, FOCU-000779, FOCU-000780, FOCU-000781, FOCU-000782, FOCU-000783, FOCU-000784, FOCU-000785, focu-000786, FOCU-000787, FOCU-000788, FOCU-000789, FOCU-000790, FOCU-000791, FOCU-000792, FOCU-000793, FOCU-000794, FOCU-000795, focu-000796, FOCU-000797, FOCU-000798, FOCU-000799, FOCU-000800, FOCU-000801, FOCU-000802, FOCU-000803, FOCU-000804, focu-000805, FOCU-000806, FOCU-000807, FOCU-000808, focu-000809, FOCU-000812, focu-000813, focu-000814, FOCU-000815, FOCU-000816, FOCU-000817, FOCU-000818, focu-000819, focu-000820, focu-000821, focu-000822, focu-000823, focu-000824, focu-000825, focu-000826, focu-000827, focu-000828, focu-000829, focu-000830, focu-000831, focu-000832, focu-000833, focu-000834, focu-000835, focu-000836, focu-000837, focu-000838, focu-000839, focu-000840, FOCU-000841, FOCU-000842, FOCU-000843, FOCU-000844, FOCU-000845, FOCU-000846, FOCU-000847, FOCU-000848, FOCU-000849, FOCU-000850, FOCU-000853, FOCU-000854, focu-00767, focu-00768, FOCU-100001, FOCU-100001, FOCU-100002, focu-100003, FOCU-100004, focu-100005, focu-100006, focu-100007, focu-100008, focu-100009, focu-100016, focu-100017, focu-100018, focu-100019, focu-100020, focu-100021, focu-100022, focu-100023, focu-100024, focu-100025, focu-100026, focu-100027, focu-100028, focu-100031, focu-100032, focu-100033, focu-100034, focu-100035, focu-100036, focu-100037, focu-100038, focu-100039, FOCU-100040, FOCU-100041, FOCU-100042, FOCU-100043, FOCU-100044, FOCU-100045, FOCU-100046, FOCU-100047, FOCU-100048, FOCU-100049, FOCU-100050, FOCU-100051, FOCU-100052, focu-100053, focu-100054, focu-100055, focu-100056, FOCU-100057, FOCU-100058, FOCU-100059, FOCU-100060, focu-100069, focu-100070, focu-100071, focu-100072, focu-100073, focu-100074, focu-100075, focu-100082, focu-100083, focu-100084, FOCU-100085, FOCU-100087, FOCU-100088, FOCU-100089, FOCU-100090, FOCU-100091, FOCU-100092, FOCU-100093, FOCU-100094, FOCU-100095, FOCU-100096, FOCU-100097, FOCU-100098, focu-100099, focu-100100, focu-100101, focu-100102, focu-100103, focu-100104, focu-100105, focu-100106, focu-100107, focu-100108, focu-100109, focu-100110, FOCU-100111, focu-100112, FOCU-100113, focu-100114, FOCU-100115, FOCU-100116, FOCU-100117, FOCU-100118, FOCU-100119, FOCU-100120, FOCU-100121, FOCU-100122, FOCU-100123, FOCU-100124, FOCU-100125, FOCU-100126, FOCU-100127, FOCU-100128, FOCU-100129, FOCU-100130, FOCU-100131, FOCU-100132, FOCU-100133, FOCU-100134, FOCU-100135, FOCU-100136, FOCU-100137, FOCU-100138, FOCU-100139, FOCU-100140, FOCU-100141, FOCU-100142, FOCU-100143, FOCU-100144, FOCU-100145, FOCU-100146, FOCU-100147, FOCU-100148, FOCU-100149, FOCU-100150, FOCU-100151, FOCU-100152, FOCU-100153, FOCU-100154, FOCU-100155, FOCU-100156, focu-100157, focu-100158, focu-100159, focu-100160, focu-100161, focu-100162, focu-100163, FOCU-100164, FOCU-100165, focu-100179, focu-100180, focu-100181, focu-100182, focu-100183, focu-100184, focu-100185, focu-100186, focu-100187, focu-100188, focu-100189, focu-100190, focu-100191, focu-100192, FOCU-100193, FOCU-100194, FOCU-100195, FOCU-100196, FOCU-100197, FOCU-100198, FOCU-100199, FOCU-100200, FOCU-100201, FOCU-100202, FOCU-100203, FOCU-100204, FOCU-100205, FOCU-100206, FOCU-100207, FOCU-100208, FOCU-100209, FOCU-100210, FOCU-100211, focu-100212, focu-100213, focu-100214, focu-100215, focu-100216, focu-100217, FOCU-100218, FOCU-100219, focu-100220, focu-100221, focu-100222, focu-100223, focu-100224, focu-100225, focu-100226, FOCU-100227, FOCU-100228, FOCU-100229, FOCU-100230, FOCU-100231, focu-100232, focu-100233, focu-100234, focu-100235, focu-100236, FOCU-100237, FOCU-100238, FOCU-100239, FOCU-100240, FOCU-100241, FOCU-100242, FOCU-100243, focu-100244, FOCU-100245, FOCU-100246, FOCU-100247, FOCU-100248, FOCU-100249, FOCU-100250, FOCU-100251, FOCU-100252, FOCU-100253, FOCU-100254, FOCU-100255, FOCU-100256, FOCU-100257, FOCU-100258, FOCU-100259, FOCU-100260, FOCU-100261, FOCU-100262, FOCU-100263, FOCU-100264, FOCU-100265, FOCU-100266, FOCU-100267, FOCU-100268, FOCU-100269, FOCU-100270, FOCU-100271, FOCU-100272, FOCU-100273, FOCU-100274, FOCU-100275, focu-100276, focu-100277, focu-100278, focu-100279, focu-100280, focu-100281, focu-100282, focu-100283, focu-100284, focu-100285, FOCU-100286, FOCU-100287, focu-100288, focu-100289, focu-100290, FOCU-100291, FOCU-100292, focu-100293, focu-100294, focu-100295, focu-100296, focu-100297, focu-100298, focu-100299, focu-100300, focu-100301, focu-100302, focu-100303, focu-100304, focu-100305, focu-100306, focu-100307, focu-100308, focu-100309, focu-100310, focu-100311, focu-100312, focu-100313, focu-100314, focu-100315, FOCU-100316, FOCU-100317, FOCU-100318, FOCU-100319, focu-100320, focu-100321, focu-100322, focu-100323, focu-100324, focu-100325, focu-100326, focu-100327, focu-100328, focu-100329, FOCU-100330, focu-100331, focu-100332, focu-100333, focu-100334, focu-100335, focu-100336, focu-100337, focu-100338, focu-100339, focu-100340, focu-100341, focu-100342, focu-100343, focu-100344, focu-100345, focu-100346, focu-100347, focu-100348, FOCU-100349, focu-100350, focu-100351, focu-100352, focu-100353, focu-100354, focu-100355, focu-100356, focu-100357, focu-100358, focu-100359, focu-100360, focu-100361, focu-100362, focu-100363, focu-100364, focu-100365, focu-100366, focu-100367, focu-100368, focu-100369, focu-100370, focu-100371, focu-100372, focu-100373, focu-100374, focu-100375, focu-100376, focu-100377, focu-100378, focu-100379, focu-100380, focu-100381, focu-100382, focu-100383, focu-100384, focu-100385, focu-100386, focu-100387, focu-100388, focu-100389, focu-100390, focu-100391, focu-100392, focu-100393, focu-100394, focu-100395, focu-100396, focu-100397, focu-100398, focu-100399, focu-100400, focu-100401, focu-100402, focu-100403, focu-100404, focu-100405, focu-100406, focu-100407, focu-100408, focu-100409, focu-100410, focu-100411, FOCU-100412, FOCU-100413, FOCU-100414, FOCU-100415, FOCU-100416, FOCU-100417, FOCU-100418, FOCU-100419, focu-100420, focu-100421, focu-100422, focu-100423, focu-100424, focu-100425, focu-100426, focu-100427, focu-100428, focu-100429, focu-100430, focu-100431, focu-100432, focu-100433, focu-100434, focu-100435, focu-100436, focu-100437, focu-100438, focu-100439, focu-100440, focu-100441, focu-100442, focu-100443, focu-100444, focu-100445, focu-100446, focu-100447, focu-100448, focu-100449, focu-100450, focu-100451, focu-100452, focu-100453, focu-100454, focu-100455, focu-100456, focu-100457, focu-100458, focu-100459, focu-100460, focu-100461, focu-100462, focu-100463, focu-100464, focu-100465, focu-100466, focu-100467, focu-100468, focu-100469, focu-100470, focu-100471, focu-100472, focu-100473, FOCU-100474, focu-100475, focu-100476, focu-100477, focu-100478, focu-100479, focu-100480, focu-100481, focu-100482, focu-100483, focu-100484, focu-100485, focu-100486, focu-100487, focu-100488, focu-100489, focu-100490, focu-100491, focu-100492, focu-100493, focu-100494, focu-100495, focu-100496, focu-100497, focu-100498, focu-100499, focu-100500, focu-100501, focu-100502, focu-100503, focu-100504, focu-100505, focu-100506, focu-100507, focu-100508, focu-100509, focu-100510, focu-100511, focu-100512, focu-100513, FOCU-100514, focu-100515, focu-100516, focu-100517, focu-100518, focu-100519, focu-100520, focu-100521, focu-100522, focu-100523, focu-100524, focu-100525, focu-100526, focu-100527, focu-100528, focu-100529, focu-100530, focu-100531, focu-100532, focu-100533, focu-100534, FOCU-100535, FOCU-100536, FOCU-100537, FOCU-100538, FOCU-100539, FOCU-100540, FOCU-100541, FOCU-100542, FOCU-100543, FOCU-100544, FOCU-100545, FOCU-100546, FOCU-100547, FOCU-100548, FOCU-100549, FOCU-100550, FOCU-100551, FOCU-100552, focu-100553, focu-100554, focu-100555, focu-100556, focu-100557, focu-100558, focu-100559, focu-100560, focu-100561, focu-100562, focu-100563, focu-100564, focu-100565, focu-100566, focu-100567, focu-100568, focu-100569, focu-100570, focu-100571, focu-100572, focu-100573, focu-100574, focu-100575, focu-100576, focu-100577, focu-100578, focu-100579, focu-100580, focu-100581, focu-100582, focu-100583, focu-100584, focu-100585, focu-100586, focu-100587, focu-100588, focu-100589, focu-100590, focu-100591, focu-100592, focu-100593, focu-100594, focu-100595, focu-100596, focu-100597, FOCU-100598, FOCU-100599, FOCU-100600, FOCU-100601, FOCU-100602, FOCU-100603, focu-100604, focu-100605, focu-100606, focu-100607, focu-100608, focu-100609, focu-100610, focu-100611, focu-100612, focu-100613, focu-100614, focu-100615, focu-100616, focu-100617, focu-100618, focu-100619, focu-100620, focu-100621, focu-100622, focu-100623, focu-100624, focu-100625, focu-100626, focu-100627, focu-100628, focu-100629, focu-100630, focu-100631, focu-100632, focu-100633, focu-100634, focu-100635, FOCU-100636, FOCU-100637, focu-100638, FOCU-100639, FOCU-100640, focu-100641, focu-100642, focu-100643, FOCU-100644, FOCU-100645, FOCU-100646, FOCU-100647, focu-100648, focu-100649, focu-100650, focu-100651, focu-100652, FOCU-100653, FOCU-100654, FOCU-100655, FOCU-100656, FOCU-100657, FOCU-100658, FOCU-100659, FOCU-100660, FOCU-100661, focu-100662, focu-100663, focu-100664, focu-100665, focu-100666, focu-100667, focu-100668, focu-100669, focu-100670, focu-100671, focu-100672, focu-100673, focu-100674, focu-100675, focu-100676, focu-100677, focu-100678, focu-100679, focu-100680, focu-100681, focu-100682, focu-100683, focu-100684, focu-100685, focu-100686, focu-100687, focu-100688, focu-100689, focu-100690, focu-100691, focu-100692, focu-100693, focu-100694, focu-100695, focu-100696, focu-100697, focu-100698, focu-100699, focu-100700, focu-100701, focu-100702, focu-100703, focu-100704, focu-100705, focu-100706, FOCU-100707, focu-100708, focu-100709, focu-100710, focu-100711, focu-100712, focu-100713, focu-100714, focu-100715, focu-100716, focu-100717, focu-100718, focu-100719, focu-100720, focu-100721, focu-100722, focu-100723, focu-100724, focu-100725, focu-100726, focu-100727, focu-100728, focu-100729, focu-100730, focu-100731, focu-100732, focu-100733, focu-100734, focu-100735, focu-100736, focu-100737, focu-100738, focu-100739, focu-100740, focu-100741, focu-100742, focu-100743, focu-100744, focu-100745, focu-100746, focu-100747, focu-100748, focu-100749, focu-100750, focu-100751, focu-100752, focu-100753, focu-100754, focu-100755, focu-100756, focu-100757, focu-100758, focu-100759, focu-100760, focu-100761, focu-100762, focu-100763, focu-100764, focu-100765, focu-100766, focu-100769, focu-100770, focu-100771, focu-100800, focu-100801, focu-100802, focu-100803, focu-100804, focu-100805, focu-100806, focu-100807, focu-100808, focu-100809, focu-100810, focu-100811, focu-100812, focu-100813, focu-100814, focu-100815, focu-100816, focu-100817, focu-100818, focu-100819, focu-100820, focu-100821, focu-100822, focu-100823, focu-100824, focu-100825, focu-100826, focu-100827, focu-100828, focu-100829, focu-100830, focu-100831, focu-100832, focu-100833, focu-100834, focu-100835, focu-100836, focu-100837, focu-100838, focu-100839, focu-100840, focu-100841, focu-100842, focu-100843, focu-100844, focu-100845, focu-100846, focu-100847, focu-100848, focu-100849, focu-100850, focu-100851, focu-100852, focu-100853, focu-100854, focu-100855, focu-100856, focu-100857, focu-100858, focu-100859, focu-100860, focu-100861, focu-100862, focu-100863, focu-100864, focu-100865, focu-100866, focu-100867, focu-100868, focu-100869, focu-100870, focu-100871, FOCU-100872, FOCU-100873, FOCU-100874, focu-100875, focu-100876, focu-100877, focu-100878, focu-100879, focu-100880, focu-100881, focu-100882, focu-100883, focu-100884, focu-100885, focu-100886, focu-100887, focu-100888, focu-100889, focu-100890, focu-100891, focu-100892, focu-100893, focu-100894, focu-100895, focu-100896, focu-100897, focu-100898, focu-100899, focu-100900, focu-100901, focu-100902, focu-100903, focu-100904, focu-100905, focu-100906, focu-100907, focu-100908, focu-100909, focu-100910, focu-100911, focu-100912, focu-100913, focu-100914, focu-100915, focu-100916, FOCU-100917, FOCU-100918, FOCU-100919, FOCU-100920, FOCU-100921, FOCU-100922, FOCU-100923, FOCU-100924, FOCU-100925, FOCU-100926, FOCU-100927, FOCU-100928, FOCU-100929, FOCU-100930, FOCU-100931, FOCU-100932, FOCU-100933, FOCU-100934, FOCU-100935, FOCU-100936, FOCU-100937, FOCU-100938, FOCU-100939, FOCU-100940, FOCU-100941, FOCU-100942, FOCU-100943, FOCU-100944, FOCU-100945, FOCU-100946, FOCU-100947, FOCU-100948, FOCU-100949, FOCU-100950, FOCU-100951, FOCU-100952, FOCU-100953, FOCU-100954, FOCU-100955, FOCU-100956, FOCU-100957, FOCU-100958, FOCU-100959, FOCU-100960, FOCU-100961, FOCU-100962, FOCU-100963, focu-100964, focu-100965, focu-100966, focu-100967, focu-100968, focu-100969, focu-100970, focu-100971, focu-100972, focu-100973, FOCU-100974, FOCU-100975, FOCU-100976, FOCU-100977, FOCU-100978, FOCU-100979, FOCU-100980, FOCU-100981, FOCU-100982, FOCU-100983, FOCU-100984, FOCU-100985, FOCU-100986, focu-100987, focu-100988, focu-100989, focu-100990, focu-100991, focu-100992, focu-100993, focu-100994, focu-100995, focu-100996, focu-100997, focu-100998, focu-100999, focu-101000, focu-101001, focu-101002, focu-101003, focu-101004, focu-101005, focu-101006, focu-101007, focu-101008, focu-101009, focu-101010, focu-101011, focu-101012, focu-101013, focu-101014, focu-101015, focu-101016, focu-101017, focu-101018, focu-101019, focu-101020, FOCU-101021, focu-101022, focu-101023, focu-101024, focu-101025, focu-101026, focu-101027, FOCU-101028, FOCU-101029, FOCU-101030, FOCU-101031, FOCU-101032, FOCU-101033, FOCU-101034, FOCU-101035, FOCU-101036, FOCU-101037, FOCU-101038, FOCU-101039, FOCU-101040, FOCU-101041, FOCU-101042, FOCU-101043, FOCU-101044, FOCU-101045, FOCU-101046, FOCU-101047, focu-101048, focu-101049, focu-101050, focu-101051, focu-101052, focu-101053, FOCU-101054, focu-101055, focu-101056, focu-101057, focu-101058, focu-101059, focu-101060, focu-101066, FOCU-101067, FOCU-101068, focu-101069, focu-101070, focu-101071, FOCU-101080, FOCU-101081, FOCU-101082, FOCU-101083, focu-101084, focu-101089, FOCU-101090, focu-101091, focu-101092, focu-101093, focu-101094, focu-101095, focu-101096, focu-101097, focu-101098, FOCU-101099, FOCU-101100, FOCU-101101, FOCU-101102, FOCU-101103, focu-101104, focu-101105, focu-101106, focu-101107, focu-101108, focu-101109, focu-101110, focu-101111, focu-101112, focu-101113, focu-101114, FOCU-101115, FOCU-101116, FOCU-101117, FOCU-101118, FOCU-101119, FOCU-101120, focu-101121, focu-101122, focu-101123, focu-101124, focu-101125, focu-101126, focu-101127, focu-101128, focu-101129, focu-101130, focu-101131, focu-101132, FOCU-101133, FOCU-101134, focu-101135, focu-101136, FOCU-101137, FOCU-101138, FOCU-101139, FOCU-101140, FOCU-101141, FOCU-101142, FOCU-101143, FOCU-101144, FOCU-101145, FOCU-101146, FOCU-101147, FOCU-101148, FOCU-101149, FOCU-101150, FOCU-101151, FOCU-101152, FOCU-101153, FOCU-101154, focu-101155, focu-101156, focu-101157, focu-101158, focu-101159, focu-101160, focu-101161, FOCU-101162, FOCU-101163, FOCU-101164, FOCU-101165, FOCU-101166, FOCU-101167, FOCU-101168, FOCU-101169, FOCU-101170, FOCU-101171, FOCU-101172, FOCU-101173, FOCU-101174, FOCU-101175, FOCU-101176, FOCU-101177, FOCU-101178, FOCU-101179, FOCU-101180, FOCU-101181, FOCU-101182, FOCU-101183, FOCU-101184, FOCU-101185, FOCU-101186, FOCU-101187, FOCU-101188.FOCU-101189, FOCU-101190, FOCU-101191, FOCU-101192, FOCU-101193, FOCU-101194, FOCU-101195, FOCU-101196, FOCU-101197, FOCU-101198, FOCU-101199, FOCU-101200, FOCU-101201, FOCU-101202, FOCU-101203, FOCU-101204, FOCU-101205, FOCU-101206, FOCU-101207, FOCU-101208, FOCU-101209, FOCU-101210, FOCU-101211, FOCU-101212, FOCU-101213, FOCU-101214, FOCU-101215, FOCU-101216, FOCU-101217, FOCU-101218, FOCU-101219, FOCU-101220, FOCU-101221, FOCU-101222, FOCU-101223, FOCU-101224, FOCU-101225, FOCU-101226, FOCU-101227, FOCU-101228, FOCU-101229, FOCU-101230, FOCU-101231, FOCU-101232, FOCU-101233, FOCU-101234, FOCU-101235, FOCU-101236, FOCU-101237, FOCU-101238, FOCU-101239, FOCU-101240, FOCU-101241, FOCU-101242, FOCU-101243, FOCU-101244, focu-101245, FOCU-101246, focu-101247, focu-101248, focu-101249, focu-101250, focu-101251, focu-101252, focu-101253, focu-101254, focu-101255, focu-101256, focu-101257, focu-101258, focu-101259, focu-101260, focu-101261, focu-101262, focu-101263, focu-101264, focu-101265, focu-101266, focu-101267, focu-101268, focu-101269, focu-101270, focu-101271, focu-101272, focu-101273, focu-101274, focu-101275, focu-101276, focu-101277, focu-101278, focu-101279, focu-101280, focu-101281, focu-101282, focu-101283, focu-101284, focu-101285, focu-101286, focu-101287, focu-101288, focu-101290, focu-101291, focu-101292, focu-101293, focu-101294, focu-101295, focu-101296, focu-101297, focu-101298, focu-101299, focu-101300, focu-101301, focu-101302, focu-101303, focu-101304, focu-101305, focu-101306, focu-101308, focu-101309, focu-101310, focu-101311, focu-101312, focu-101313, focu-101314, focu-101315, focu-101316, focu-101317, focu-101318, focu-101319, focu-101320, focu-101321, focu-101322, FOCU-101323, FOCU-101324, FOCU-101325, FOCU-101326, FOCU-101327, focu-101328, focu-101329, focu-101330, focu-101331, focu-101332, focu-101333, focu-101334, focu-101335, focu-101336, focu-101337, focu-101338, focu-101339, focu-101340, focu-101343, FOCU-101344, FOCU-101345, FOCU-101346, FOCU-101347, FOCU-101348, FOCU-101349, FOCU-101350, FOCU-101351, FOCU-101352, FOCU-101353, FOCU-101354, FOCU-101355, focu-101356, focu-101357, focu-101358, focu-101359, focu-101360, FOCU-101361, focu-101362, FOCU-101363, FOCU-101364, FOCU-101365, FOCU-101366, FOCU-101367, FOCU-101368, FOCU-101369, focu-101370, focu-101371, focu-101372, focu-101373, focu-101374, focu-101375, focu-101376, focu-101377, focu-101378, focu-101379, focu-101380, focu-101381, focu-101382, focu-101383, focu-101384, focu-101385, focu-101386, focu-101387, focu-101388, focu-101389, focu-101390, focu-101391, focu-101392, focu-101393, focu-101394, FOCU-101395, FOCU-101396, FOCU-101397, FOCU-101398, FOCU-101399, FOCU-101400, FOCU-101401, FOCU-101402, FOCU-101403, FOCU-101404, FOCU-101405, FOCU-101406, FOCU-101407, FOCU-101408, FOCU-101409, FOCU-101410, FOCU-101411, FOCU-101412, FOCU-101413, focu-101414, focu-101415, focu-101416, focu-101417, focu-101418, focu-101419, focu-101420, focu-101421, FOCU-101422, FOCU-101423, FOCU-101424, FOCU-101425, FOCU-101426, FOCU-101427, FOCU-101428, FOCU-101429, FOCU-101430, FOCU-101431, FOCU-101432, FOCU-101433, FOCU-101434, FOCU-101435, FOCU-101436, FOCU-101437, FOCU-101438, FOCU-101439, FOCU-101440, FOCU-101441, FOCU-101442, FOCU-101443, FOCU-101444, FOCU-101445, FOCU-101446, FOCU-101447, FOCU-101448, FOCU-101449, FOCU-101450, FOCU-101451, FOCU-101452, FOCU-101453, FOCU-101454, FOCU-101455, FOCU-101456, FOCU-101457, FOCU-101458, FOCU-101459, FOCU-101460, FOCU-101461, FOCU-101462, FOCU-101463, FOCU-101464, FOCU-101465, FOCU-101468, FOCU-101469, FOCU-101470, FOCU-101471, FOCU-101472, FOCU-101473, FOCU-101474, FOCU-101475, FOCU-101476, FOCU-101477, FOCU-101478, FOCU-101479, FOCU-101480, FOCU-101481, FOCU-101482, FOCU-101483, FOCU-101484, FOCU-101485, FOCU-101486, FOCU-101491, FOCU-101492, FOCU-101493, FOCU-101494, FOCU-101495, FOCU-101496, FOCU-101497, FOCU-101498, FOCU-101499, FOCU-101500, FOCU-101501, FOCU-101502, focu-101504, FOCU-101505, focu-101506, focu-101507, FOCU-101508, FOCU-101509, FOCU-101510, FOCU-101511, FOCU-101512, FOCU-101513, FOCU-101514, FOCU-101515, FOCU-101516, FOCU-101517, FOCU-101518, FOCU-101519, FOCU-101520, FOCU-101521, FOCU-101522, FOCU-101523, FOCU-101524, FOCU-101525, FOCU-101526, FOCU-101527, FOCU-101528, FOCU-101529, FOCU-101530, FOCU-101531, FOCU-101532, FOCU-101533, FOCU-101534, FOCU-101535, FOCU-101536, FOCU-101537, FOCU-101538, FOCU-101539, FOCU-101540, FOCU-101541, FOCU-101542, FOCU-101543, FOCU-101544, FOCU-101545, FOCU-101546, FOCU-101547, FOCU-101548, FOCU-101549, FOCU-101550, FOCU-101551, FOCU-101552, FOCU-101553, focu-101554, Focu-101555, focu-101556, FOCU-101557, FOCU-101558, FOCU-101559, FOCU-101560, FOCU-101561, FOCU-101562, FOCU-101563, FOCU-101564, FOCU-101565, FOCU-101566, FOCU-101567, focu-101568, focu-101569, FOCU-101570, FOCU-101571, FOCU-101572, FOCU-101573, FOCU-101574, FOCU-101575, FOCU-101576, FOCU-101577, FOCU-101578, FOCU-101579, FOCU-101580, FOCU-101581, FOCU-101582, FOCU-101583, FOCU-101584, FOCU-101585, FOCU-101586, FOCU-101587, FOCU-101588, FOCU-101589, FOCU-101590, FOCU-101591, FOCU-101592, FOCU-101593, FOCU-101594, FOCU-101595, FOCU-101596, FOCU-101597, FOCU-101598, FOCU-101599, FOCU-101600, FOCU-101601, FOCU-101602, FOCU-101603, FOCU-101604, FOCU-101605, FOCU-101606, FOCU-101607, FOCU-101608, FOCU-101609, FOCU-101610, FOCU-101611, FOCU-101612, FOCU-101613, FOCU-101614, FOCU-101615, FOCU-101616, focu-101617, focu-101618, focu-101619, focu-101620, focu-101621, focu-101622, focu-101623, focu-101624, focu-101625, focu-101626, focu-101627, focu-101628, focu-101629, focu-101630, focu-101631, focu-101632, focu-101633, focu-101634, focu-101635, focu-101636, focu-101637, focu-101638, focu-101639, focu-101640, focu-101641, focu-101642, focu-101643, focu-101644, FOCU-101645, focu-101646, focu-101647, FOCU-101648, focu-101649, focu-101650, focu-101651, FOCU-101652, FOCU-101653, FOCU-101654, FOCU-101655, FOCU-101656, FOCU-101657, focu-101658, focu-101659, focu-101660, focu-101661, focu-101662, focu-101663, focu-101664, focu-101665, focu-101666, focu-101667, focu-101668, focu-101669, focu-101670, focu-101671, focu-101672, focu-101673, focu-101674, focu-101675, focu-101676, focu-101677, focu-101678, focu-101679, focu-101680, focu-101681, focu-101682, FOCU-101683, focu-101684, focu-101685, FOCU-101686, FOCU-101687, FOCU-101688, FOCU-101689, FOCU-101690, FOCU-101691, FOCU-101692, FOCU-101693, FOCU-101694, FOCU-101695, focu-101698, focu-101699, focu-101700, focu-101701, focu-101702, FOCU-101704, FOCU-101705, FOCU-101706, FOCU-101707, FOCU-101708, FOCU-101709, FOCU-101710, FOCU-101711, FOCU-101712, FOCU-101713, FOCU-101714, FOCU-101715, focu-101716, focu-101717, focu-101718, focu-101719, focu-101720, focu-101721, focu-101722, focu-101723, focu-101724, focu-101725, focu-101726, focu-101727, focu-101728, focu-101729, FOCU-101730, FOCU-101731, FOCU-101732, FOCU-101733, FOCU-101734, FOCU-101735, FOCU-101736, FOCU-101737, FOCU-101738, FOCU-101739, FOCU-101740, FOCU-101741, FOCU-101742, FOCU-101743, FOCU-101744, FOCU-101745, FOCU-101746, FOCU-101747, focu-101748, FOCU-101749, focu-101750, FOCU-101751, FOCU-101752, FOCU-101753, FOCU-101754, FOCU-101755, FOCU-101756, FOCU-101757, FOCU-101758, FOCU-101759, FOCU-101760, FOCU-101761, FOCU-101762, FOCU-101763, FOCU-101764, FOCU-101765, FOCU-101766, FOCU-101767, FOCU-101768, FOCU-101769, FOCU-101770, FOCU-101771, FOCU-101772, FOCU-101773, FOCU-101774, FOCU-101775, FOCU-101776, FOCU-101777, FOCU-101778, focu-101779, FOCU-101780, FOCU-101781, FOCU-101782, FOCU-101783, FOCU-101784, FOCU-101785, FOCU-101786, FOCU-101787, FOCU-101788, FOCU-101789, FOCU-101790, FOCU-101791, FOCU-101792, FOCU-101793, FOCU-101794, FOCU-101800, FOCU-101801, FOCU-101802, FOCU-101803, FOCU-101804, FOCU-101805, FOCU-101806, FOCU-101807, FOCU-101808, FOCU-101809, FOCU-101810, focu-101811, focu-101812, focu-101813, FOCU-101814, FOCU-101815, FOCU-101816, FOCU-101817, FOCU-101818, FOCU-101819, FOCU-101820, focu-101821, focu-101822, focu-101823, FOCU-101827, FOCU-101828, FOCU-101829, FOCU-101830, focu-101831, focu-101832, focu-101833, focu-101834, focu-101835, focu-101836, focu-101837, focu-101838, focu-101839, focu-101840, focu-101841, FOCU-101842, FOCU-101843, FOCU-101844, focu-101845, FOCU-101846, FOCU-101847, FOCU-101848, FOCU-101849, FOCU-101850, FOCU-101851, FOCU-101852, FOCU-101853, FOCU-101854, FOCU-101855, FOCU-101856, FOCU-101857, FOCU-101858, FOCU-101859, FOCU-101860, focu-101861, focu-101862, focu-101863, focu-101864, focu-101865, FOCU-101866, FOCU-101867, FOCU-101868, FOCU-101869, FOCU-101870, FOCU-101871, FOCU-101872, FOCU-101873, FOCU-101874, FOCU-101875, FOCU-101876, FOCU-101877, FOCU-101878, FOCU-101879, FOCU-101880, FOCU-101882, FOCU-101883, FOCU-101884, FOCU-101885, FOCU-101886, FOCU-101887, FOCU-101888, FOCU-101889, FOCU-101890, focu-101891, focu-101892, focu-101893, focu-101894, focu-101895, focu-101896, focu-101897, FOCU-101898, FOCU-101899, FOCU-101900, FOCU-101901, FOCU-101902, FOCU-101903, FOCU-101904, FOCU-101905, FOCU-101906, FOCU-101907, FOCU-101908, FOCU-101910, FOCU-101911, FOCU-101912, FOCU-101913, FOCU-101914, FOCU-101915, focu-101926, focu-101927, FUCU-000426, FUCU-000427, FUCU-000428, FUCU-000429, FUCU-000430, FUCU-000431, FUCU-000432, FUCU-000433, FUCU-000434, FUCU-000435, FUCU-000436, FUCU-000437, FUCU-000438, FUCU-000439, FUCU-000440, FUCU-000441, FUCU-000442, FUCU-000443, FUCU-000444, FUCU-000445, FUCU-000446, FUCU-000447, FUCU-000448, FUCU-000449, FUCU-000450, FUCU-000451, FUCU-000452, FUCU-000453, FUCU-000744, FUCU-000745, FUCU-000746, FUCU-000747, FUCU-000748, FUCU-000749, FUCU-100166, FUCU-100167, FUCU-100168, FUCU-100169, FUCU-100170, FUCU-100171, FUCU-100172, FUCU-100173, FUCU-100174, FUCU-100175, FUCU-100176, FUCU-100177, and FUCU-100178.    Serial numbers for the ventilators in other countries:  VENT-001034, VENT-001036, VENT-001037, VENT-001038, VENT-001039, VENT-001040, VENT-001041, VENT-001042, VENT-001043, VENT-001044, VENT-001045, VENT-001046, VENT-001048, VENT-001049, VENT-001050, VENT-001051, VENT-001052, VENT-001053, VENT-001054, VENT-001055, VENT-001056, VENT-001057, VENT-001058, VENT-001059, VENT-001060, VENT-001061, VENT-001062, VENT-001063, VENT-001064, VENT-001065, VENT-001067, VENT-001069, VENT-001070, VENT-001071, VENT-001072, VENT-001073, VENT-001074, VENT-001075, VENT-001077, VENT-001078, VENT-001080, VENT-001082, VENT-001083, VENT-001084, VENT-001085, VENT-001086, VENT-001087, VENT-001089, VENT-001090, VENT-001096, VENT-001097, VENT-001098, VENT-001113, VENT-001114, VENT-001171, VENT-001172, VENT-001173, VENT-001174, VENT-001175, VENT-001176, VENT-001177, vent-001179, vent-001180, vent-001181, vent-001182, vent-001183, vent-001202, vent-001203, VENT-001286, VENT-001288, VENT-001289, VENT-001290, VENT-001321, VENT-001322, VENT-001323, VENT-001324, VENT-001336, vent-001339, VENT-001340, vent-001341, VENT-001342, VENT-001346, VENT-001456, vent-001458, VENT-001469, VENT-001550, VENT-001552, VENT-001557, VENT-001558, VENT-001559, VENT-001560, VENT-001567, VENT-001568, VENT-001569, VENT-001570, VENT-001571, VENT-001572, VENT-001620, VENT-001753, vent-001856, vent-001875, VENT-001889, VENT-001893, VENT-001896, VENT-001898, VENT-001933, VENT-001934, VENT-001935, VENT-001937, VENT-001938, VENT-001939, VENT-001940, VENT-001941, VENT-001955, VENT-001958, VENT-001959, vent-001966, VENT-001978, vent-001979, VENT-001981, vent-001983, VENT-001984, VENT-001989, VENT-001993, VENT-001994, VENT-001996, VENT-001997, VENT-001998, VENT-001999, VENT-002002, VENT-002004, VENT-002005, VENT-002006, VENT-002007, VENT-002009, VENT-002010, VENT-002011, VENT-002012, VENT-002013, VENT-002014, VENT-002015, VENT-002016, VENT-002017, VENT-002019, VENT-002020, VENT-002022, VENT-002023, VENT-002024, VENT-002026, VENT-002031, VENT-002033, VENT-002034, VENT-002036, VENT-002037, VENT-002038, VENT-002039, VENT-002040, VENT-002042, VENT-002046, VENT-002052, VENT-002068, VENT-002071, VENT-002107, VENT-002110, VENT-002111, VENT-002112, VENT-002113, VENT-002114, VENT-002116, VENT-002117, VENT-002119, VENT-002123, VENT-002124, VENT-002125, VENT-002126, VENT-002127, VENT-002128, VENT-002129, VENT-002130, VENT-002131, VENT-002132, VENT-002133, VENT-002136, VENT-002137, VENT-002138, VENT-002140, VENT-002141, VENT-002142, VENT-002143, VENT-002144, VENT-002145, VENT-002146, VENT-002151, VENT-002152, VENT-002153, VENT-002154, VENT-002155, VENT-002157, VENT-002163, VENT-002167, VENT-002170, VENT-002172, VENT-002173, VENT-002174, vent-002175, vent-002179, vent-002180, vent-002181, vent-002182, vent-002183, vent-002184, vent-002187, vent-002189, vent-002190, vent-002191, vent-002192, vent-002193, vent-002194, vent-002195, vent-002196, vent-002197, vent-002198, vent-002199, vent-002200, vent-002217, vent-002218, vent-002260, vent-002261, vent-002262, vent-002263, vent-002264, vent-002265, vent-002266, vent-002267, vent-002268, vent-002269, vent-002279, vent-002280, vent-002281, vent-002282, vent-002283, vent-002284, vent-002285, vent-002286, vent-002287, vent-002288, vent-002289, VENT-002328, VENT-002330, VENT-002331, VENT-002341, vent-002351, vent-002355, VENT-002358, vent-002431, vent-002432, vent-002438, vent-002440, vent-002441, vent-002442, vent-002443, vent-002444, vent-002445, vent-002446, vent-002448, VENT-002452, VENT-002453, VENT-002454, VENT-002455, VENT-002458, VENT-002459, VENT-002460, VENT-002461, vent-002462, VENT-002463, VENT-002465, VENT-002466, VENT-002468, vent-002469, vent-002470, VENT-002471, vent-002472, vent-002473, vent-002474, vent-002476, vent-002478, vent-002479, vent-002482, vent-002484, vent-002485, vent-002486, vent-002487, vent-002488, vent-002489, vent-002490, vent-002492, vent-002493, vent-002494, vent-002495, vent-002496, vent-002497, vent-002498, vent-002499, vent-002500, VENT-002501, vent-002502, VENT-002505, VENT-002506, VENT-002508, VENT-002509, VENT-002510, VENT-002511, VENT-002512, VENT-002513, VENT-002514, VENT-002516, VENT-002518, VENT-002519, VENT-002520, VENT-002526, VENT-002527, VENT-002528, VENT-002530, VENT-002531, VENT-002532, VENT-002535, VENT-002536, VENT-002538, VENT-002541, VENT-002542, VENT-002545, vent-002546, vent-002547, VENT-002550, VENT-002551, VENT-002552, VENT-002554, VENT-002555, VENT-002556, VENT-002568, VENT-002569, VENT-002570, VENT-002571, VENT-002572, VENT-002573, VENT-002574, VENT-002575, VENT-002578, VENT-002579, VENT-002585, VENT-002586, vent-002595, vent-002601, VENT-002602, vent-002603, VENT-002604, VENT-002605, VENT-002607, VENT-002608, VENT-002609, VENT-002610, VENT-002611, VENT-002667, VENT-002670, VENT-002671, VENT-002672, VENT-002673, VENT-002674, VENT-002675, VENT-002676, VENT-002679, VENT-002680, VENT-002681, VENT-002682, VENT-002683, VENT-002684, VENT-002688, VENT-002689, VENT-002694, VENT-002695, VENT-002696, VENT-002708, VENT-002711, VENT-002712, VENT-002713, VENT-002714, VENT-002715, VENT-002716, VENT-002717, VENT-002718, VENT-002719, VENT-002720, VENT-002721, VENT-002722, VENT-002724, VENT-002725, VENT-002726, VENT-002729, VENT-002730, VENT-002732, VENT-002733, VENT-002734, VENT-002735, VENT-002736, VENT-002737, VENT-002739, VENT-002740, VENT-002741, VENT-002742, VENT-002743, VENT-002744, vent-002745, VENT-002746, vent-002747, VENT-002748, vent-002749, vent-002750, vent-002751, vent-002752, vent-002753, vent-002754, vent-002755, vent-002756, VENT-002757, vent-002758, vent-002759, vent-002760, VENT-002761, VENT-002762, VENT-002763, VENT-002764, VENT-002765, VENT-002766, VENT-002767, VENT-002768, VENT-002769, VENT-002770, VENT-002771, VENT-002772, VENT-002773, VENT-002774, VENT-002775, VENT-002776, VENT-002777, VENT-002779, VENT-002780, VENT-002783, VENT-002784, VENT-002785, VENT-002786, VENT-002787, VENT-002788, VENT-002789, VENT-002790, VENT-002791, VENT-002793, VENT-002794, VENT-002795, VENT-002796, VENT-002798, VENT-002799, VENT-002800, vent-002801, vent-002832, vent-002857, vent-002868, vent-002873, vent-002896, vent-002909, vent-002916, vent-003005, vent-003006, vent-003007, vent-003008, vent-003009, vent-003010, VENT-003016, vent-003069, vent-003140, vent-003141, vent-003142, vent-003148, vent-003149, vent-003150, vent-003151, vent-003153, vent-003154, vent-003155, vent-003195, vent-003202, vent-003203, vent-003204, vent-003205, vent-003206, vent-003207, vent-003208, vent-003209, vent-003210, vent-003211, vent-003212, vent-003215, vent-003219, vent-003222, vent-003223, vent-003224, vent-003240, vent-003241, vent-003272, vent-003278, vent-003280, vent-003281, vent-003282, vent-003283, vent-003290, vent-003324, vent-003331, vent-003343, vent-003344, vent-003346, vent-003348, vent-003351, vent-003358, vent-003448, vent-003619, vent-003630, vent-003631, vent-003632, vent-003634, vent-003664, vent-003670, vent-003671, vent-003672, vent-003673, vent-003675, vent-003676, vent-003678, vent-003679, vent-003680, vent-003681, vent-003682, vent-003683, vent-003684, vent-003685, vent-003686, vent-003687, vent-003688, vent-003691, vent-003692, vent-003693, vent-003697, vent-003699, vent-003704, vent-003706, vent-003719, vent-003722, vent-003723, vent-003727, vent-003728, vent-003729, vent-003876, vent-003882, vent-003884, vent-003885, vent-004025, vent-004036, vent-004172, vent-004179, vent-004200, vent-004203, vent-004204, vent-004206, vent-004225, vent-004229, vent-004230, vent-004238, vent-004243, vent-004275, vent-004276, vent-004277, vent-004278, vent-004279, vent-004281, vent-004282, vent-004283, vent-004284, vent-004285, vent-004286, vent-004287, vent-004288, vent-004291, vent-004295, vent-004297, vent-004298, vent-004301, vent-004303, vent-004304, vent-004306, vent-004307, vent-004308, vent-004310, vent-004311, vent-004313, vent-004314, vent-004315, vent-004316, vent-004317, vent-004318, vent-004319, vent-004320, vent-004321, vent-004322, vent-004323, vent-004324, vent-004325, vent-004326, vent-004327, vent-004328, vent-004329, vent-004330, vent-004331, vent-004332, vent-004333, vent-004334, vent-004335, vent-004337, vent-004342, vent-004611, vent-004612, vent-004613, vent-004616, vent-004617, vent-004619, vent-004620, vent-004762, vent-004767, vent-004770, vent-004771, vent-004773, vent-004776, vent-004779, vent-004786, vent-004787, vent-004790, vent-004794, vent-004798, vent-004800, vent-004801, vent-004802, vent-004803, vent-004806, vent-004807, vent-004808, vent-004809, vent-004810, vent-004811, vent-004812, vent-004813, vent-004816, vent-004817, vent-004818, vent-004819, vent-004820, vent-004821, vent-004824, vent-004825, vent-004826, vent-004827, vent-004828, vent-004829, vent-004830, vent-004831, vent-004835, vent-004836, vent-004837, vent-004838, vent-004839, vent-004840, vent-004842, vent-004843, vent-004845, vent-004846, vent-004850, vent-004853, vent-004926, vent-004927, vent-004928, vent-004930, vent-004931, vent-004932, vent-004933, vent-004934, vent-004935, vent-004937, vent-004938, vent-004939, vent-004940, vent-004941, vent-004942, vent-004943, vent-004944, vent-004948, vent-004951, vent-004953, vent-004956, vent-004959, vent-004960, vent-004961, vent-004965, vent-004968, vent-004969, vent-004971, vent-004972, vent-004973, vent-004974, vent-004975, vent-004976, VENT-004977, VENT-004978, VENT-004979, VENT-004980, VENT-004981, VENT-004982, VENT-004983, vent-004984, VENT-004985, VENT-004986, VENT-004987, VENT-004988, VENT-004989, VENT-004990, VENT-004991, VENT-004992, VENT-004993, VENT-004994, VENT-004995, VENT-004996, VENT-004999, VENT-005000, VENT-005008, VENT-005009, VENT-005010, VENT-005011, VENT-005012, VENT-005013, VENT-005015, VENT-005017, VENT-005018, VENT-005019, VENT-005020, VENT-005022, VENT-005023, VENT-005025, VENT-005032, VENT-005033, VENT-005034, VENT-005035, VENT-005037, VENT-005039, VENT-005042, VENT-005043, VENT-005044, VENT-005045, VENT-005046, VENT-005047, VENT-005050, VENT-005054, VENT-005057, VENT-005070, VENT-005071, VENT-005072, VENT-005073, VENT-005074, VENT-005075, VENT-005076, VENT-005077, VENT-005078, VENT-005080, VENT-005081, VENT-005082, VENT-005083, VENT-005084, VENT-005086, VENT-005087, VENT-005088, VENT-005104, vent-005107, vent-005108, vent-005109, vent-005110, vent-005111, vent-005112, VENT-005114, VENT-005116, VENT-005118, VENT-005119, VENT-005121, VENT-005122, VENT-005123, VENT-005127, VENT-005129, VENT-005137, VENT-005138, VENT-005139, VENT-005140, VENT-005142, VENT-005143, VENT-005147, VENT-005148, VENT-005149, VENT-005150, VENT-005151, VENT-005152, VENT-005153, VENT-005154, VENT-005155, VENT-005160, VENT-005161, VENT-005165, VENT-005166, VENT-005167, VENT-005168, VENT-005169, VENT-005171, VENT-005179, VENT-005307, VENT-005403, VENT-005407, VENT-005574, VENT-005585, VENT-005586, VENT-005587, VENT-005589, VENT-005590, VENT-005591, vent-005771, vent-005772, vent-005773, vent-005774, vent-005775, VENT-005783, VENT-005784, VENT-005785, VENT-005786.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
  • Descripción del producto
    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. || In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S
  • Modelo / Serial
    SERIAL NUMBER IN THE US: 3300-203410   SERIAL NUMBERS INTERNATIONAL: 3300-203361, 3300-203362, 3300-203363, 3300-203364, 3300-203386, 3300-203387, 3300-203388, 3300-203389, 3300-203390, 3300-203391, 3300-203392, 3300-203393, 3300-203394, 3300-203395, 3300-203396, 3300-203397, 3300-203398, 3300-203399, 3300-203400, 3300-203401, 3300-203402, 3300-203403, 3300-203404, 3300-203405, 3300-203406, 3300-203407, 3300-203408, 3300-203409, 3300-203410, 3300-203443, 3300-203444, 3300-203445, 3300-203446, 3300-203447, 3300-203448, 3300-203449, 3300-203450, 3300-203451, 3300-203452, 3300-203453, 3300-203454, 3300-203455, 3300-203456, 3300-203457, 3300-203458, 3300-203459, 3300-203460, 3300-203461, 3300-203462, 3300-203463, 3300-203464, 3300-203465, 3300-203466, 3300-203467, 3300-203468, 3300-203469, 3300-203470, 3300-203471, 3300-203472, 3300-203473, 3300-203474, 3300-203475, 3300-203476, 3300-203477, 3300-203478, 3300-203479, 3300-203480, 3300-203481, 3300-203482, 3300-203483, 3300-203484, 3300-203485, 3300-203486, 3300-203487, 3300-203488, 3300-203489, 3300-203490, 3300-203491, 3300-203492, 3300-203501, 3300-203502, 3300-203503, 3300-203504, 3300-203505, 3300-203506, 3300-203507, 3300-203508, 3300-203509, and 3300-203511.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.
  • Descripción del producto
    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S
Device Recall Spacelabs Healthcare G2 Clinical Access CD
  • Modelo / Serial
    Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.  Serial numbers distributed in the US: "040-1565-10" and "063-1829-11".   Serial number distributed outside the US: "063-1829-11".
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.
  • Descripción del producto
    Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. || Used for installing ICS G2 Clinical Access software onto hospital personal computers.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare G2 Clinical Access CD
Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281
  • Modelo / Serial
    Serial Numbers IN the US:  6281- 002002, 6281- 002003, 6281- 002004, 6281- 002005, 6281- 002006, 6281- 002007, 6281- 002008, 6281- 002009, 6281- 002010, 6281- 002011, 6281- 002012, 6281- 002013, 6281-000295, 6281-000401, 6281-000402, 6281-000403, 6281-000404, 6281-000405, 6281-000406, 6281-000407, 6281-000408, 6281-000503, 6281-000504, 6281-000505, 6281-000506, 6281-000507, 6281-000508, 6281-000512, 6281-000513, 6281-000514, 6281-000515, 6281-000516, 6281-000517, 6281-000518, 6281-000519, 6281-000520, 6281-000521, 6281-000522, 6281-000523, 6281-000524, 6281-000526, 6281-000527, 6281-000528, 6281-000529, 6281-000530, 6281-000531, 6281-000532, 6281-000533, 6281-000534, 6281-000535, 6281-000536, 6281-000537, 6281-000538, 6281-000539, 6281-000540, 6281-000541, 6281-000542, 6281-000543, 6281-000544, 6281-000545, 6281-000546, 6281-000547, 6281-000549, 6281-000550, 6281-000551, 6281-000552, 6281-000553, 6281-000554, 6281-000555, 6281-000556, 6281-000557, 6281-000558, 6281-000559, 6281-000560, 6281-000561, 6281-000562, 6281-000563, 6281-000564, 6281-000565, 6281-000566, 6281-000567, 6281-000570, 6281-000574, 6281-000575, 6281-000576, 6281-000577, 6281-000578, 6281-000579, 6281-000580, 6281-000581, 6281-000582, 6281-000583, 6281-000584, 6281-000585, 6281-000586, 6281-000587, 6281-000588, 6281-000589, 6281-000590, 6281-000591, 6281-000592, 6281-000593, 6281-000594, 6281-000595, 6281-000596, 6281-000597, 6281-000598, 6281-000599, 6281-000600, 6281-000601, 6281-000602, 6281-000603, 6281-000604, 6281-000605, 6281-000606, 6281-000607, 6281-000608, 6281-000609, 6281-000610, 6281-000611, 6281-000612, 6281-000613, 6281-000614, 6281-000615, 6281-000616, 6281-000617, 6281-000618, 6281-000619, 6281-000620, 6281-000621, 6281-000622, 6281-000623, 6281-000624, 6281-000625, 6281-000626, 6281-000627, 6281-000628, 6281-000629, 6281-000630, 6281-000631, 6281-000632, 6281-000633, 6281-000634, 6281-000635, 6281-000636, 6281-000637, 6281-000638, 6281-000639, 6281-000640, 6281-000641, 6281-000642, 6281-000643, 6281-000644, 6281-000645, 6281-000646, 6281-000647, 6281-000648, 6281-000649, 6281-000650, 6281-000651, 6281-000652, 6281-000653, 6281-000654, 6281-000655, 6281-000656, 6281-000657, 6281-000658, 6281-000659, 6281-000660, 6281-000661, 6281-000662, 6281-000663, 6281-000664, 6281-000665, 6281-000666, 6281-000667, 6281-000668, 6281-000669, 6281-000670, 6281-000671, 6281-000672, 6281-000673, 6281-000674, 6281-000675, 6281-000676, 6281-000677, 6281-000678, 6281-000679, 6281-000680, 6281-000681, 6281-000682, 6281-000683, 6281-000684, 6281-000685, 6281-000686, 6281-000687, 6281-000688, 6281-000689, 6281-000690, 6281-000691, 6281-000692, 6281-000693, 6281-000694, 6281-000695, 6281-000696, 6281-000697, 6281-000698, 6281-000699, 6281-000700, 6281-000701, 6281-000702, 6281-000703, 6281-000704, 6281-000705, 6281-000706, 6281-000707, 6281-000708, 6281-000709, 6281-000710, 6281-000711, 6281-000712, 6281-000713, 6281-000714, 6281-000715, 6281-000716, 6281-000717, 6281-000718, 6281-000719, 6281-000720, 6281-000721, 6281-000722, 6281-000723, 6281-000724, 6281-000725, 6281-000853, 6281-000854, 6281-000855, 6281-000856, 6281-000857, 6281-000858, 6281-000859, 6281-000860, 6281-000861, 6281-000862, 6281-000863, 6281-000864, 6281-000865, 6281-000866, 6281-000867, 6281-000868, 6281-000869, 6281-000870, 6281-000871, 6281-000872, 6281-000938, 6281-000939, 6281-000940, 6281-000941, 6281-000942, 6281-000943, 6281-000944, 6281-000945, 6281-000946, 6281-000947, 6281-000948, 6281-000949, 6281-000950, 6281-000951, 6281-000952, 6281-000953, 6281-000954, 6281-000955, 6281-000956, 6281-000957, 6281-000958, 6281-000959, 6281-000960, 6281-000961, 6281-000962, 6281-000963, 6281-000964, 6281-000965, 6281-000966, 6281-000967, 6281-000968, 6281-000969, 6281-000970, 6281-000971, 6281-000972, 6281-000973, 6281-000974, 6281-000975, 6281-000976, 6281-000977, 6281-000978, 6281-000979, 6281-000981, 6281-000982, 6281-000983, 6281-000984, 6281-000985, 6281-000986, 6281-000987, 6281-000988, 6281-000989, 6281-000990, 6281-000991, 6281-000992, 6281-001005, 6281-001006, 6281-001007, 6281-001008, 6281-001009, 6281-001010, 6281-001011, 6281-001012, 6281-001013, 6281-001014, 6281-001015, 6281-001016, 6281-001017, 6281-001018, 6281-001019, 6281-001020, 6281-001021, 6281-001022, 6281-001023, 6281-001024, 6281-001025, 6281-001026, 6281-001027, 6281-001028, 6281-001029, 6281-001030, 6281-001031, 6281-001036, 6281-001037, 6281-001080, 6281-001081, 6281-001082, 6281-001083, 6281-001084, 6281-001085, 6281-001086, 6281-001087, 6281-001088, 6281-001089, 6281-001090, 6281-001091, 6281-001092, 6281-001093, 6281-001094, 6281-001095, 6281-001096, 6281-001097, 6281-001098, 6281-001099, 6281-001100, 6281-001101, 6281-001102, 6281-001103, 6281-001104, 6281-001105, 6281-001106, 6281-001107, 6281-001108, 6281-001109, 6281-001110, 6281-001111, 6281-001112, 6281-001113, 6281-001114, 6281-001115, 6281-001116, 6281-001117, 6281-001118, 6281-001119, 6281-001120, 6281-001121, 6281-001122, 6281-001123, 6281-001124, 6281-001125, 6281-001126, 6281-001127, 6281-001128, 6281-001129, 6281-001130, 6281-001131, 6281-001132, 6281-001133, 6281-001134, 6281-001135, 6281-001136, 6281-001137, 6281-001138, 6281-001139, 6281-001140, 6281-001141, 6281-001142, 6281-001143, 6281-001144, 6281-001145, 6281-001146, 6281-001147, 6281-001148, 6281-001149, 6281-001150, 6281-001151, 6281-001152, 6281-001153, 6281-001154, 6281-001155, 6281-001156, 6281-001157, 6281-001158, 6281-001159, 6281-001160, 6281-001161, 6281-001162, 6281-001163, 6281-001164, 6281-001165, 6281-001166, 6281-001167, 6281-001168, 6281-001169, 6281-001170, 6281-001171, 6281-001178, 6281-001179, 6281-001180, 6281-001181, 6281-001182, 6281-001183, 6281-001184, 6281-001185, 6281-001186, 6281-001187, 6281-001188, 6281-001189, 6281-001190, 6281-001191, 6281-001192, 6281-001193, 6281-001194, 6281-001195, 6281-001196, 6281-001197, 6281-001222, 6281-001223, 6281-001224, 6281-001225, 6281-001226, 6281-001227, 6281-001228, 6281-001229, 6281-001230, 6281-001231, 6281-001232, 6281-001233, 6281-001234, 6281-001235, 6281-001236, 6281-001237, 6281-001238, 6281-001239, 6281-001240, 6281-001241, 6281-001242, 6281-001243, 6281-001244, 6281-001245, 6281-001246, 6281-001247, 6281-001248, 6281-001249, 6281-001250, 6281-001251, 6281-001252, 6281-001253, 6281-001254, 6281-001255, 6281-001256, 6281-001257, 6281-001258, 6281-001259, 6281-001260, 6281-001261, 6281-001262, 6281-001263, 6281-001264, 6281-001265, 6281-001266, 6281-001267, 6281-001268, 6281-001269, 6281-001270, 6281-001271, 6281-001272, 6281-001273, 6281-001274, 6281-001275, 6281-001276, 6281-001277, 6281-001278, 6281-001279, 6281-001280, 6281-001281, 6281-001282, 6281-001283, 6281-001284, 6281-001285, 6281-001286, 6281-001287, 6281-001288, 6281-001289, 6281-001290, 6281-001291, 6281-001292, 6281-001293, 6281-001294, 6281-001295, 6281-001296, 6281-001297, 6281-001298, 6281-001299, 6281-001300, 6281-001301, 6281-001302, 6281-001303, 6281-001304, 6281-001305, 6281-001306, 6281-001307, 6281-001308, 6281-001309, 6281-001310, 6281-001311, 6281-001312, 6281-001313, 6281-001314, 6281-001315, 6281-001316, 6281-001317, 6281-001318, 6281-001319, 6281-001320, 6281-001321, 6281-001322, 6281-001323, 6281-001331, 6281-001332, 6281-001337, 6281-001338, 6281-001390, 6281-001391, 6281-001392, 6281-001393, 6281-001394, 6281-001395, 6281-001396, 6281-001397, 6281-001398, 6281-001399, 6281-001400, 6281-001401, 6281-001402, 6281-001403, 6281-001404, 6281-001405, 6281-001406, 6281-001407, 6281-001408, 6281-001409, 6281-001410, 6281-001412, 6281-001413, 6281-001414, 6281-001415, 6281-001416, 6281-001417, 6281-001418, 6281-001419, 6281-001420, 6281-001421, 6281-001422, 6281-001423, 6281-001424, 6281-001425, 6281-001426, 6281-001427, 6281-001428, 6281-001429, 6281-001430, 6281-001431, 6281-001432, 6281-001433, 6281-001434, 6281-001435, 6281-001436, 6281-001437, 6281-001438, 6281-001439, 6281-001440, 6281-001441, 6281-001449, 6281-001450, 6281-001451, 6281-001452, 6281-001453, 6281-001454, 6281-001459, 6281-001468, 6281-001469, 6281-001470, 6281-001471, 6281-001472, 6281-001595, 6281-001596, 6281-001597, 6281-001598, 6281-001610, 6281-001611, 6281-001615, 6281-001616, 6281-001648, 6281-001802, 6281-001803, 6281-001804, 6281-001805, 6281-001806, 6281-001807, 6281-001808, 6281-001809, 6281-001810, 6281-001811, 6281-001812, 6281-001813, 6281-001814, 6281-001815, 6281-001816, 6281-001817, 6281-001818, 6281-001819, 6281-001820, 6281-001914, 6281-001915, 6281-001916, 6281-001917, 6281-001918, 6281-001919, 6281-001920, 6281-001921, 6281-001922, 6281-001923, 6281-001924, 6281-001925, 6281-001926, 6281-001927, 6281-001928, 6281-001929, 6281-001930, 6281-001931, 6281-001932, 6281-001933, 6281-001934, 6281-001935, 6281-001936, 6281-001937, 6281-001938, 6281-001939, 6281-001940, 6281-001941, 6281-001942, 6281-001943, 6281-001944, 6281-001945, 6281-001946, 6281-001947, 6281-001948, 6281-001949, 6281-001950, 6281-001951, 6281-001952, 6281-001953, 6281-001954, 6281-001955, 6281-001956, 6281-001957, 6281-001958, 6281-001959, 6281-001960, 6281-001961, 6281-001962, 6281-001963, 6281-001964, 6281-001965, 6281-001966, 6281-001967, 6281-001968, 6281-001969, 6281-001970, 6281-001971, 6281-001972, 6281-001973, 6281-001974, 6281-001975, 6281-001976, 6281-001977, 6281-001978, 6281-001979, 6281-001980, 6281-001998, 6281-002014, 6281-002015, 6281-002016, 6281-002017, 6281-002018, 6281-002019, 6281-002020, 6281-002021, 6281-002022, 6281-002023, 6281-002024, 6281-002025, 6281-002026, 6281-002027, 6281-002028, 6281-002029, 6281-002030, 6281-002031, 6281-002032, 6281-002033, 6281-002034, 6281-002035, 6281-002036, 6281-002037, 6281-002038, 6281-002039, 6281-002040, 6281-002041, 6281-002042, 6281-002043, 6281-002044, 6281-002045, 6281-002046, 6281-002047, 6281-002048, 6281-002049, 6281-002050, 6281-002051, 6281-002052, 6281-002053, 6281-002054, 6281-002055, 6281-002056, 6281-002057, 6281-002058, 6281-002059, 6281-002060, 6281-002061, 6281-002062, 6281-002063, 6281-002064, 6281-002065, 6281-002066, 6281-002067, 6281-002068, 6281-002069, 6281-002070, 6281-002071, 6281-002072, 6281-002073, 6281-002074, 6281-002075, 6281-002076, 6281-002077, 6281-002078, 6281-002079, 6281-002080, 6281-002081, 6281-002082, 6281-002083, 6281-002084, 6281-002085, 6281-002086, 6281-002087, 6281-002088, 6281-002089, 6281-00209 , 6281-002090, 6281-002091, 6281-002092, 6281-002093, 6281-002094, 6281-002095, 6281-002096, 6281-002100, 6281-002101, 6281-002102, 6281-002103, 6281-002104, 6281-002105, 6281-002106, 6281-002107, 6281-002108, 6281-002109, 6281-002110, 6281-002111, 6281-002112, 6281-002113, 6281-002114, 6281-002115, 6281-002116, 6281-002117, 6281-002118, 6281-002119, 6281-002120, 6281-002121, 6281-002122, 6281-002123, 6281-002124, 6281-002125, 6281-002126, 6281-002127, 6281-002128, 6281-002129, 6281-002130, 6281-002131, 6281-002132, 6281-002133, 6281-002134, 6281-002135, 6281-002136, 6281-002137, 6281-002138, 6281-002139, 6281-002140, 6281-002141, 6281-002142, 6281-002143, 6281-002144, 6281-002145, 6281-002146, 6281-002147, 6281-002148, 6281-002149, 6281-002150, 6281-002151, 6281-002152, 6281-002153, 6281-002154, 6281-002155, 6281-002156, 6281-002157, 6281-002158, 6281-002159, 6281-002160, 6281-002161, 6281-002162, 6281-002163, 6281-002164, 6281-002165, 6281-002166, 6281-002167, 6281-002168, 6281-002169, 6281-002170, 6281-002171, 6281-002172, 6281-002173, 6281-002174, 6281-002175, 6281-002176, 6281-002177, 6281-002178, 6281-002179, 6281-002180, 6281-002181, 6281-002182, 6281-002183, 6281-002184, 6281-002185, 6281-002186, 6281-002187, 6281-002188, 6281-002189, 6281-002190, 6281-002191, 6281-002375, 6281-002376, 6281-002377, 6281-002378, 6281-002379, 6281-002380, 6281-002381, 6281-002382, 6281-002383, 6281-002384, 6281-002507, 6281-002545, 6281-002546, 6281-002547, 6281-002548, 6281-002549, 6281-002550, 6281-002551, 6281-002552, 6281-002553, 6281-002554, 6281-002555, 6281-002556, 6281-002557, 6281-002558, 6281-002559, 6281-002560, 6281-002561, 6281-002562, 6281-002563, 6281-002564, 6281-002565, 6281-002566, 6281-002567, 6281-002568, 6281-002569, 6281-002570, 6281-002571, 6281-002572, 6281-002573, 6281-002574, 6281-002575, 6281-002576, 6281-002577, 6281-002578, 6281-002579, 6281-002580, 6281-002581, 6281-002582, 6281-002583, 6281-002584, 6281-002585, 6281-002586, 6281-002587, 6281-002588, 6281-002589, 6281-002590, 6281-002591, 6281-002592, 6281-002593, 6281-002594, 6281-002595, 6281-002596, 6281-002597, 6281-002598, 6281-002599, 6281-002600, 6281-002601, 6281-002602, 6281-002603, 6281-002604, 6281-002605, 6281-002606, 6281-002607, 6281-002608, 6281-002609, 6281-002610, 6281-002611, 6281-002612, 6281-002613, 6281-002614, 6281-002615, 6281-002616, 6281-002617, 6281-002618, 6281-002619, 6281-002620, 6281-002621, 6281-002622, 6281-002623, 6281-002624, 6281-002625, 6281-002626, 6281-002627, 6281-002681, 6281-002682, 6281-002683, and 6281-002684.  SERIAL NUMBERS OUTSIDE THE US:  6281-000451, 6281-000771, 6281-000772, 6281-000773, 6281-000774, 6281-000775, 6281-000776, 6281-000993, 6281-000994, 6281-000995, 6281-000996, 6281-000997, 6281-000998, 6281-000999, 6281-001000, 6281-001001, 6281-001002, 6281-001003, 6281-001004, 6281-001038, 6281-001039, 6281-001040, 6281-001041, 6281-001042, 6281-001043, 6281-001044, 6281-001045, 6281-001046, 6281-001047, 6281-001048, 6281-001049, 6281-001050, 6281-001051, 6281-001052, 6281-001053, 6281-001054, 6281-001055, 6281-001056, 6281-001057, 6281-001058, 6281-001059, 6281-001060, 6281-001061, 6281-001062, 6281-001063, 6281-001064, 6281-001065, 6281-001066, 6281-001067, 6281-001068, 6281-001069, 6281-001070, 6281-001071, 6281-001172, 6281-001173, 6281-001174, 6281-001175, 6281-001475, 6281-001476, 6281-001514, 6281-001515, 6281-001516, 6281-001517, 6281-001705, 6281-001706, 6281-001994, 6281-001995, 6281-001996, and 6281-001997.   Spacelabs is currently conducting a internal audit and discovered that there are additional lot numbers for this recall. 6681-003056, 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, and 6281-002664.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.
  • Descripción del producto
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. || Model 96281 is intended for use with either adult or neonatal patient || populations in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ARIATELE TELEMETRY TRANSMITTER, Model 96281
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.