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  • Dispositivo 153
  • Fabricante 42
  • Evento 124969
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Vital Signs Monitor, Model 93300
  • Modelo / Serial
    Model 93300. Serial numbers: 3300-000001, 3300-000002, 3300-000003, 3300-000005, 3300-000006, 3300-000007, 3300-000008, 3300-000009, 3300-000010, 3300-000011, 3300-000012, 3300-000013, 3300-000014, 3300-000015, 3300-000016, 3300-000017, 3300-000018, 3300-000019, 3300-000020, 3300-000021, 3300-000022, 3300-000023, 3300-000024, 3300-000026, 3300-000027, 3300-000028, 3300-000029, 3300-000030, 3300-000031, 3300-000032, 3300-000033, 3300-000034, 3300-000035, 3300-000036, 3300-000037, 3300-000038, 3300-000039, 3300-000040, 3300-000041, 3300-000042, 3300-000043, 3300-000044, 3300-000045, 3300-000046, 3300-000047, 3300-000049, 3300-000050, 3300-000052, 3300-000053, 3300-000054, 3300-000055, 3300-000056, 3300-000057, 3300-000058, 3300-000059, 3300-000060, 3300-000061, 3300-000062, 3300-000063, 3300-000064, 3300-000065, 3300-000066, 3300-000067, 3300-000068, 3300-000069, 3300-000070, 3300-000071, 3300-000072, 3300-000073, 3300-000074, 3300-000075, 3300-000076, 3300-000077, 3300-000078, 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3300-100182, 3300-100183, 3300-100184, 3300-100185, 3300-100186, 3300-100187, 3300-100188, 3300-100196, 3300-100197, 3300-100198, 3300-100199, 3300-100200, 3300-100201, 3300-100202, 3300-100203, 3300-100204, 3300-100205, 3300-100206, 3300-100207, 3300-100208, 3300-100209, 3300-100210, 3300-100211, 3300-100212, 3300-100213, 3300-100214, 3300-100215, 3300-100216, 3300-100217, 3300-100218, 3300-100219, 3300-100220, 3300-100221, 3300-100222, 3300-100223, 3300-100224, 3300-100225, 3300-100226, 3300-100227, 3300-100228, 3300-100229, 3300-100230, 3300-100231, 3300-100232, 3300-100233, 3300-100234, 3300-100235, 3300-100236, 3300-100237, 3300-100238, 3300-100239, 3300-100240, 3300-100241, 3300-100242, 3300-100243, 3300-100244, 3300-100245, 3300-100246, 3300-100247, 3300-100248, 3300-100249, 3300-100250, 3300-100251, 3300-100252, 3300-100253, 3300-100254, 3300-100255, 3300-100256, 3300-100260, 3300-100261, 3300-100262, 3300-100264, 3300-100266, 3300-100267, 3300-100268, 3300-100269, 3300-100270, 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93300-100046, 93300-100047, 93300-100049, 93300-100050, 93300-100053, 93300-100054, 93300-100062, 93300-100063, 93300-100064, 93300-100067, 93300-100068, 93300-100070, 93300-100073, 93300-100074, 93300-100075, 93300-100076, 93300-100077, 93300-100080, 93300-100081, 93300-100084, 93300-100085, 93300-100090, 93300-100092, 93300-100096, 93300-100097, 93300-100100, 93300-100104, 93300-100105, 93300-100106, 93300-100107, 93300-100108, 93300-100109, 93300-100110, 93300-100111, 93300-100112, 93300-100113, 93300-100114, 93300-100115, 93300-100116, 93300-100117, 93300-100118, 93300-100120, 93300-100121, 93300-100122, 93300-100123, 93300-100124, 93300-100125, 93300-100126, 93300-100127, 93300-100128, 93300-100129, 93300-100130, 93300-100131, 93300-100132, 93300-100133, 93300-100258, 93300-100259, 93300-100263, AND 93300-100265.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MACEDONIA, MALAYSIA, NEPAL, NETHERLANDS, NICARAGUA, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU, PUERTO RICO, PHILIPPINES, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
  • Descripción del producto
    Spacelabs Medical elance Vital Signs Monitor, Model 93300. || The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Vital Signs Monitor, Model 93300
Spacelabs Healthcare Xhibit Central Station
  • Modelo / Serial
    Software version 1.1.5, Affected Serial Numbers in the US ************************************* ADDITIONAL FIVE UNITS ADDED:  SLA0216F01796; SLA0216F01808; SLA1215F01638; SLA1215F01645; SLA1215F01652;   SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0115F00955, SLA0115F00961, SLA0115F00968, SLA0115F00969, SLA0115F00972, SLA0115F00976, SLA0116F01718, SLA0116F01720, SLA0116F01722, SLA0214F00489, SLA0216F01807, SLA0216F01809, SLA0216F01813, SLA0216F01821, SLA0216F01824, SLA0216F01837, SLA0216F01840, SLA0216F01844, SLA0314F00534, SLA0314F00535, SLA0314F00540, SLA0314F00543, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00552, SLA0314F00561, SLA0314F00567, SLA0414F00568, SLA0414F00585, SLA0416F01850, SLA0416F01853, SLA0416F01857, SLA0416F01860, SLA0416F01875, SLA0416F01876, SLA0416F01883, SLA0416F01885, SLA0416F01889, SLA0416F01895, SLA0416F01923, SLA0516F01969, SLA0516F01970, SLA0516F01972, SLA0516F01974, SLA0516F01975, SLA0516F01976, SLA0516F01977, SLA0516F01978, SLA0516F01981, SLA0516F01982, SLA0516F01985, SLA0516F01986, SLA0516F01987, SLA0516F01992, SLA0516F02002, SLA0516F02005, SLA0614F00631, SLA0614F00654, SLA0615F01188, SLA0615F01194, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01213, SLA0615F01237, SLA0615F01238, SLA0615F01239, SLA0615F01240, SLA0615F01244, SLA0615F01248, SLA0615F01261, SLA0714F00678, SLA0714F00688, SLA0714F00694, SLA0714F00702, SLA0714F00703, SLA0715F01274, SLA0715F01310, SLA0715F01314, SLA0715F01325, SLA0715F01331, SLA0715F01334, SLA0715F01346, SLA0715F01347, SLA0716F02009, SLA0716F02011, SLA0716F02013, SLA0716F02015, SLA0716F02016, SLA0716F02017, SLA0716F02020, SLA0716F02021, SLA0716F02022, SLA0716F02028, SLA0716F02034, SLA0716F02042, SLA0716F02043, SLA0716F02044, SLA0716F02045, SLA0814F00713, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01391, SLA0815F01395, SLA0815F01397, SLA0815F01400, SLA0815F01402, SLA0815F01403, SLA0815F01404, SLA0815F01405, SLA0815F01406, SLA0815F01407, SLA0815F01408, SLA0815F01409, SLA0815F01412, SLA0815F01415, SLA0815F01418, SLA0815F01419, SLA0815F01424, SLA0816F02048, SLA0816F02050, SLA0816F02051, SLA0816F02052, SLA0816F02053, SLA0816F02054, SLA0816F02055, SLA0816F02056, SLA0816F02057, SLA0816F02058, SLA0816F02059, SLA0816F02060, SLA0816F02061, SLA0816F02062, SLA0816F02063, SLA0816F02065, SLA0816F02066, SLA0816F02067, SLA0816F02074, SLA0816F02075, SLA0816F02076, SLA0816F02077, SLA0816F02078, SLA0816F02081, SLA0816F02082, SLA0816F02083, SLA0816F02085, SLA0816F02087, SLA0816F02089, SLA0816F02091, SLA0816F02092, SLA0816F02093, SLA0816F02094, SLA0816F02095, SLA0816F02096, SLA0816F02097, SLA0816F02098, SLA0816F02099, SLA0816F02100, SLA0816F02101, SLA0816F02102, SLA0816F02103, SLA0816F02104, SLA0816F02105, SLA0816F02106, SLA0816F02107, SLA0915F01439, SLA0915F01442, SLA0915F01447, SLA0915F01451, SLA0915F01452, SLA0915F01457, SLA0915F01459, SLA0915F01462, SLA0915F01468, SLA0915F01474, SLA0915F01493, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01501, SLA0915F01503, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0916F02108, SLA0916F02110, SLA0916F02111, SLA0916F02112, SLA0916F02114, SLA0916F02115, SLA0916F02117, SLA0916F02121, SLA0916F02122, SLA0916F02123, SLA0916F02126, SLA0916F02127, SLA0916F02130, SLA0916F02131, SLA0916F02132, SLA0916F02133, SLA0916F02134, SLA0916F02136, SLA0916F02137, SLA0916F02138, SLA0916F02139, SLA0916F02141, SLA0916F02142, SLA0916F02143, SLA0916F02145, SLA0916F02146, SLA0916F02147, SLA0916F02148, SLA0916F02149, SLA0916F02150, SLA0916F02153, SLA0916F02154, SLA0916F02155, SLA0916F02156, SLA0916F02158, SLA0916F02159, SLA0916F02160, SLA0916F02162, SLA0916F02163, SLA0916F02165, SLA0916F02166, SLA1015F01525, SLA1015F01528, SLA1015F01530, SLA1015F01540, SLA1015F01551, SLA1015F01560, SLA1114F00795, SLA1114F00820, SLA1115F01578, SLA1115F01579, SLA1115F01582, SLA1115F01584, SLA1115F01593, SLA1115F01594, SLA1115F01595, SLA1115F01596, SLA1115F01597, SLA1115F01599, SLA1115F01602, SLA1115F01603, SLA1115F01608, SLA1115F01609, SLA1214F00858, SLA1214F00871, SLA1214F00876, SLA1214F00881, SLA1214F00885, SLA1214F00886, and SLA1215F01632.  ***********Affected Serial Numbers OUTSIDE the US **************************  SLA0114F00430, SLA0114F00437, SLA0114F00438, SLA0114F00439, SLA0114F00440, SLA0114F00443, SLA0115F00975, SLA0116F01724, SLA0314F00528, SLA0314F00541, SLA0414F00596, SLA0416F01872, SLA0416F01877, SLA0416F01880, SLA0612F00235, SLA0715F01270, SLA0715F01271, SLA0715F01273, SLA0715F01283, SLA0715F01335, SLA0716F02023, SLA0716F02025, SLA0716F02029, SLA0716F02031, SLA0716F02035, SLA0716F02036, SLA0716F02037, SLA0716F02040, SLA0716F02041, SLA0716F02047, SLA0815F01431, SLA0816F02049, SLA0816F02064, SLA0816F02069, SLA0816F02070, SLA0816F02071, SLA0816F02072, SLA0816F02073, SLA0816F02079, SLA0816F02080, SLA0816F02084, SLA0816F02086, SLA0916F02109, SLA0916F02118, SLA0916F02119, SLA0916F02120, SLA0916F02128, SLA0916F02129, SLA0916F02140, SLA0916F02161, SLA1014F00776, SLA1113F00348, SLA1113F00368, SLA1115F01604, SLA1115F01605, and SLA1213F00389.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
  • Descripción del producto
    Xhibit Central Station, Model 96102. || Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Spacelabs Healthcare Xhibit Central Station
Spacelabs Healthcare CardioCall ECG Event Recorder
  • Modelo / Serial
    PCBAs PN #: 670-1670-00.  SERIAL NUMBERS in the US:  CARD-200990, CARD-201287, CARD-623478, CARD-623775, CARD-624198, CARD-624224, CARD-624314, CARD-624387, CARD-624404, CARD-624413, CARD-624891, CARD-625061, CARD-625089, CARD-625124, CARD-625232, CARD-625269, CARD-625296, CARD-625304, CARD-625322, and CARD-625421.  SERIAL NUMBERS OUTSIDE THE US:  CARD-000019, CARD-000028, CARD-000037, CARD-000046, CARD-000064, CARD-000073, CARD-000073, CARD-000082, CARD-000091, CARD-000109, CARD-000118, CARD-000127, CARD-000136, CARD-000145, CARD-000163, CARD-000172, CARD-000181, CARD-000190, CARD-000208, CARD-000217, CARD-000226, CARD-000235, CARD-000244, CARD-000271, CARD-000280, CARD-000299, CARD-000307, CARD-000325, CARD-000334, CARD-000343, CARD-000352, CARD-000361, CARD-000370, CARD-000398, CARD-000406, CARD-000415, CARD-000424, CARD-000433, CARD-000442, CARD-000451, CARD-000479, CARD-000479, CARD-000488, CARD-000497, CARD-000505, CARD-000514, CARD-000523, CARD-000532, CARD-000550, CARD-000578, CARD-000596, CARD-000604, CARD-000613, CARD-000622, CARD-000631, CARD-000640, CARD-000659, CARD-000668, CARD-000677, CARD-000686, CARD-000703, CARD-000721, CARD-000730, CARD-000749, CARD-000758, CARD-000767, CARD-000776, CARD-000785, CARD-000785, CARD-000794, CARD-000802, CARD-000811, CARD-000820, CARD-000820, CARD-000839, CARD-000848, CARD-000857, CARD-000866, CARD-000875, CARD-000893, CARD-000910, CARD-000910, CARD-000929, CARD-000938, CARD-000947, CARD-000956, CARD-000974, CARD-000983, CARD-000992, CARD-001009, CARD-001018, CARD-001027, CARD-001027, CARD-001036, CARD-001045, CARD-001054, CARD-001063, CARD-001072, CARD-001072, CARD-001081, CARD-001090, CARD-001108, CARD-001117, CARD-001135, CARD-001144, CARD-001153, CARD-001171, CARD-001180, CARD-001199, CARD-001199, CARD-001207, CARD-001216, CARD-001225, CARD-001234, CARD-001243, CARD-001252, CARD-001261, CARD-001270, CARD-001289, CARD-001298, CARD-001306, CARD-001315, CARD-001333, CARD-001379, CARD-001388, CARD-001397, CARD-001405, CARD-001414, CARD-001423, CARD-001441, CARD-001603, CARD-002602, CARD-003304, CARD-003601, CARD-003908, CARD-005203, CARD-006103, CARD-200035, CARD-200116, CARD-200125, CARD-200486, CARD-200963, CARD-201016, CARD-201052, CARD-201124, CARD-201133, CARD-300016, CARD-300025, CARD-300034, CARD-300052, CARD-300070, CARD-300089, CARD-300098, CARD-300160, CARD-300188, CARD-300197, CARD-300205, CARD-300214, CARD-300223, CARD-300232, CARD-300269, CARD-300278, CARD-300313, CARD-300322, CARD-300331, CARD-300368, CARD-300395, CARD-300412, CARD-300421, CARD-300430, CARD-300458, CARD-300467, CARD-300476, CARD-300494, CARD-300511, CARD-300539, CARD-300548, CARD-300566, CARD-300576, CARD-300647, CARD-300656, CARD-300674, CARD-300692, CARD-300728, CARD-300755, CARD-300773, CARD-300782, CARD-300809, CARD-300818, CARD-300836, CARD-300881, CARD-300890, CARD-300917, CARD-300926, CARD-300944, CARD-301006, CARD-301042, CARD-301079, CARD-301114, CARD-301150, CARD-301178, CARD-301439, CARD-301484, CARD-400213, CARD-621894, CARD-623973, CARD-624846, CARD-625043, CARD-625160, CARD-625188, CARD-625250, CARD-625476, CARD-625511, CARD-625665, CARD-625818, CARD-627023, CARD-627546, CARD-627555, CARD-627564, CARD-627636, CARD-627645, CARD-627654, CARD-627663, CARD-627672, CARD-627708, CARD-627726, CARD-627744, CARD-627753, CARD-627771, CARD-627780, CARD-627834, CARD-627861, CARD-627898, CARD-627960, CARD-627997, CARD-628013, CARD-628031, CARD-628059, CARD-628077, CARD-628095, CARD-628112, CARD-628176, CARD-628220, CARD-628239, CARD-630065, CARD-630137, CARD-630146, CARD-630281, CARD-630443, CARD-630461, CARD-630498, CARD-630885, CARD-631235, CARD-631271, and CARD-631307.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, QATAR, SINGAPORE, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 || Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Spacelabs Healthcare CardioCall ECG Event Recorder
Arkon Anesthesia Delivery System and Upgrade Kit 050904300
  • Modelo / Serial
    UDI: 10841522100017
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
  • Descripción del producto
    Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. || The Spacelabs Arkon 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
    Spacelabs Healthcare, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Arkon Anesthesia Delivery System and Upgrade Kit 050904300
Portable patient monitor with arrhythmia detection or alarms.
  • Modelo / Serial
    SERIAL NUMBERS: 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 1367-000112, 1367-000113, 1367-000519, 1367-000582, 1367-000583, 1367-000584, 1367-000585, 1367-000586, 1367-000587, 1367-000588, 1367-000589, 1367-000590, 1367-000591, 1367-000592, 1367-000593, 1367-000666, 1367-000667, 1367-000668, 1367-000669, 1367-000670, 1367-000778, 1367-000782, 1367-000783, 1367-000784, 1367-000785, 1367-000787, 1367-000788, 1367-000792, 1367-000794, 1367-000795, 1367-000796, 1367-000797, 1367-000801, 1367-000802, 1367-000803, 1367-000804, 1367-000805, 1367-000806, 1367-000807, 1367-000808, 1367-000809, 1367-000810, 1367-000811, 1367-000812, 1367-000814, 1367-000815, 1367-000817, 1367-000818, 1367-000819, 1367-000831, 1367-000832, 1367-000833, 1367-000876, 1367-000877, 1367-000889, 1367-000890, 1367-000969, 1367-000996, 1367-000997, 1367-001046, 1367-001047, 1367-001069, 1367-001094, 1367-001095, 1367-001096, 1367-001097, 1367-001098, 1367-001099, 1367-001100, 1367-001138, 1367-001139, 1367-001140, 1367-001141, 1367-001142, 1367-001143, 1367-001144, 1367-001145, 1367-001146, 1367-001147, 1367-001148, 1367-001149, 1367-001150, 1367-001151, 1367-001152, 1367-001153, 1367-001154, 1367-001155, 1367-001156, 1367-001157, 1367-001158, 1367-001159, 1367-001175, 1367-001176, 1367-001177, 1369-003807, 1369-004493, 1369-004494, 1369-004495, 1369-004496, 1369-005181, 1369-005182, 1369-008556, 1369-008561, 1369-008562, 1369-008699, 1369-008700, 1369-008701, 1369-008702, 1369-008703, 1369-008704, 1369-008705, 1369-008706, 1369-008707, 1369-008721, 1369-008829, 1369-008830, 1369-008831, 1369-008832, 1369-008833, 1369-008834, 1369-008835, 1369-008836, 1369-008837, 1369-008838, 1369-008839, 1369-008841, 1369-008842, 1369-008843, 1369-008844, 1369-008845, 1369-008846, 1369-008847, 1369-008848, 1369-008850, 1369-008851, 1369-008852, 1369-008853, 1369-008854, 1369-008858, 1369-008881, 1369-008884, 1369-009247, 1369-009591, 1369-009592, 1369-009593, 1369-009594, 1369-009595, 1369-009789, 1369-009793, 1369-009794, 1369-009946, 1369-010098, 1369-011656, 1369-011657, 1369-011658, 1369-011659, 1369-011681, 1369-012491, 1369-012492, 1369-012493, 1369-012494, 1369-012764, 1369-012765, 1369-012773, 1369-012824, 1369-012825, 1369-012826, 1369-012827, 1369-012843, 1369-012856, 1369-012950, 1369-012952, 1369-012953, 1369-012954, 1369-012955, 1369-012956, 1369-012972, 1369-012973, 1369-012974, 1369-012975, 1369-013045, 1369-013046, 1369-013047, 1369-013178, 1369-013179, 1369-013180, 1369-013181, 1369-013182, 1369-013183, 1369-013184, 1369-013185, 1369-013186, 1369-013187, 1369-013188, 1369-013189, 1369-013190, 1369-013191, 1369-013192, 1369-013193, 1369-013194, 1369-013195, 1369-013197, 1369-013198, 1369-013206, 1369-013207, 1369-013208, 1369-013209, 1369-013210, 1369-013211, 1369-013212, 1369-013213, 1369-013347, 1369-013348, 1369-013349, 1369-013350, 1369-013351, 1369-013352, 1369-013353, 1369-013355, 1369-013356, 1369-013357, 1369-013358, 1369-013359, 1369-013360, 1369-013522, 1369-013523, 1369-013524, 1369-013529, 1369-013530, 1369-013531, 1369-013532, 1369-013533, 1369-013534, 1369-013535, 1369-013536, 1369-013537, 1369-013615, 1369-013616, 1369-013617, 1369-013618, 1369-013619, 1369-013620, 1369-013621, 1369-013622, 1369-013623, 1369-013624, 1369-013625, 1369-013626, 1369-013627, 1369-013628, 1369-013629, 1369-013630, 1369-013632, 1369-013731, 1369-013732, 1369-013733, 1369-013734, 1369-013735, 1369-013846, 1369-013901, 1369-013902, 1369-013903, 1369-013904, 1369-013905, 1369-013906, 1369-013907, 1369-013908, 1369-013965, 1369-013966, 1369-014163, 1369-014164, 1369-014165, 1369-014166, 1369-014167, 1369-014168, 1369-014169, 1369-014170, 1369-014171, 1369-014172, 1369-014173, 1369-014174, 1369-014228, 1369-014229, 1369-014238, 1369-014290, 1369-014291, 1369-014292, 1369-014293, 1369-014294, 1369-014295, 1369-014297, 1369-014298, 1369-014299, 1369-014300, 1369-014359, 1369-014360, 1369-014493, 1369-014542, 1369-014550, 1369-014598, 1369-014613, 1369-014640, 1369-014641, 1369-014642, 1369-014660, 1369-014661, 1369-014662, 1369-014663, 1369-014664, 1369-014669, 1369-014670, 1369-014671, 1369-014867, 1369-014868, 1369-014910, 1369-014911, 1369-014912, 1369-014913, 1369-014914, 1369-014916, 1369-014917, 1369-014918, 1369-014919, 1369-014920, 1369-014921, 1369-014922, 1369-014923, 1369-014924, 1369-014925, 1369-014926, 1369-014927, 1369-014928, 1369-014929, 1369-014930, 1369-014931, 1369-014932, 1369-014933, 1369-014934, 1369-014938, 1369-014939, 1369-014940, 1369-014941, 1369-014942, 1369-014943, 1369-014944, 1369-014945, 1369-014947, 1369-014948, 1369-014959, 1369-014977, 1369-014996, 1369-014998, 1369-014999, 1369-015000, 1369-015013, 1369-015041, 1369-015114, 1370-000015, 1370-000695, 1370-000696, 1370-000697, 1370-000698, 1370-000699, 1370-000700, 1370-000701, 1370-002517, 1370-003328, 1370-003329, 1370-003330, 1370-003331, 1370-003332, 1370-003333, 1370-003335, 1370-003336, 1370-003337, 1370-003338, 1370-003339, 1370-003370, 1370-003371, 1370-003372, 1370-003373, 1370-003374, 1370-003375, 1370-003376, 1370-003377, 1370-003378, 1370-003379, 1370-003380, 1370-003381, 1370-003382, 1370-003384, 1370-003385, 1370-003386, 1370-003387, 1370-003388, 1370-003390, 1370-003391, 1370-003392, 1370-003393, 1370-003394, 1370-003395, 1370-003396, 1370-003397, 1370-003972, 1370-003973, 1370-003974, 1370-003975, 1370-003976, 1370-003977, 1370-003978, 1370-004022, 1370-004203, 1370-004207, 1370-004216, 1370-004217, 1370-004265, 1370-004266, 1370-004467, 1370-004530, 1370-004545, 1370-004546, 1370-004547, 1370-004548, 1370-004549, 1370-004550, 1370-004551, 1370-004552, 1370-004553, 1370-004554, 1370-004555, 1370-004556, 1370-004557, 1370-004558, 1370-004559, 1370-004560, 1370-004561, 1370-004617, 1370-004720, 1370-004721, 1370-004722, 1370-004723, 1370-004724, 1370-004725, 1370-004726, 1370-004727, 1370-004728, 1370-004730, 1370-004731, 1370-004732, 1370-004733, 1370-004751, 1370-004770, 1370-004771, 1370-004772, 1370-004773, 1370-004774, 1370-004775, 1370-004858, 1370-004859, 1370-004872, 1370-004873, 1370-004874, 1370-004875, 1370-004876, 1370-004877, 1370-004878, 1370-004879, 1370-004880, 1370-004881, 1370-004882, 1370-004883, 1370-004884, 1370-004885, 1370-004886, 1370-004887, 1370-004888, 1370-004889, 1370-004890, 1370-004891, 1370-004892, 1370-004893, 1370-004894, 1370-004895, 1370-004896, 1370-004897, 1370-004898, 1370-004899, 1370-004900, 1370-004901, 1370-004902, 1370-004903, 1370-004904, 1370-004905, 1370-004906, 1370-004907, 1370-004908, 1370-004909, 1370-004910, 1370-005054, 1370-005055, 1370-005056, 1370-005057, 1370-005058, 1370-005059, 1370-005060, and 1370-005061.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.
  • Descripción del producto
    Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. || Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. 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 hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Portable patient monitor with arrhythmia detection or alarms.
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390
  • Modelo / Serial
    SERIAL NUMBERS IN THE US:  1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020.   SERIAL NUMBER INTERNATIONAL:  1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976,  1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022,  1390-102023, and 1390-102024.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.
  • Descripción del producto
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. || 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. 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.
  • Manufacturer
    Spacelabs Healthcare, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Spacelabs Healthcare qube Compact Patient Monitor, Model 91390
Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system
  • Modelo / Serial
    Gemini systems
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV and GA., and to the countries of : Saudi Arabia, Indonesia, Canada, Netherlands, Hong Kong, Lebanon and Kazakhstan.
  • Descripción del producto
    American Science & Engineering Inc,Gemini Cabinet X-ray system.
  • Manufacturer
    American Science & Engineering, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system
"XPREZZON ™ Headrest Monitors", model 91393, and "qube ™ Compact Monitors", model 91390, manufact...
  • Modelo / Serial
  • Manufacturer
    Spacelabs Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para "XPREZZON ™ Headrest Monitors", model 91393, and "qube ™ Compact Monitors", model 91390, manufactured by Spacelabs Healthcare, Inc., USA
Ultraview SL Command Modules ..
  • Modelo / Serial
    SL Command Modules with Masimo SpO2 PCBA (p/n 010-1636-02) require minimum software version 2.04.04.
  • Descripción del producto
    Monitors, Physiologic, Vital Signs
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Anesthesia Machine ARKON
  • Modelo / Serial
  • Descripción del producto
    The ARKON anesthesia workstation by SPACELABS is designed to be used in hospital environments and operating theaters. It can be used to supply oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits, with or without the use of a ventilator, and can be used to administer vaporasthesic using a removable vaporizer.
  • Manufacturer
    Spacelabs Healtcare Inc || Spacelabs Healthcare Ltd
  • 1 Event
    • Alerta De Seguridad para Anesthesia Machine ARKON
Spacelabs Medical Capnography Module
  • Modelo / Serial
    Spacelabs Medical Capnography Module, model: 91517
  • Descripción del producto
    Capnography module is a mainstream and sidestream gasanalyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient’s ventilatory, circulatory, and metabolic status.
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Vital Sign Monitor Model 91220
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    Spacelabs
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Vital Sign Monitor Model 91220
Multigas-Analyzer model 91518
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    Spacelabs
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Multigas-Analyzer model 91518
Spacelabs Healthcare Patient Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices - electrodiagnostics
  • Manufacturer
    Spacelabs Healthcare Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Spacelabs Healthcare Patient Monitor
Patient Monitor, Model 91387
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    Spacelabs Healthcare Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Patient Monitor, Model 91387
Ultraview SL 2200, 2400, 2600, 2700 and XPREZZON Monitors with Perioperativ-Option
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    Spacelabs Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Ultraview SL 2200, 2400, 2600, 2700 and XPREZZON Monitors with Perioperativ-Option
Ultraview SL 2200, 2400 and 2600 Monitore with Wireless-Option
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    Spacelabs Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Ultraview SL 2200, 2400 and 2600 Monitore with Wireless-Option
élance Vital Signs Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    Spacelabs Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de élance Vital Signs Monitor
ICS G2 Clinical Access CD
  • Modelo / Serial
    G2 Clinical Access CD with the following part numbers: - PN: 063-1829-11 Rev A - Update Kit, PN: 040-1565-10
  • Descripción del producto
    application suite accessible from anywhere
  • Manufacturer
    Spacelabs Healthcare Inc
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Xhibit central station
  • Modelo / Serial
    96102, software version 1.1.5
  • Descripción del producto
    Provide physicians with central data monitoring of adult, pediatric and neonatal patient patients connected to networked patient monitors and telemetry transmitters.
  • Manufacturer
    Spacelabs Healtcare Inc || Spacelabs Healthcare Medical Equipment (Suzhou) Co, Ltd
  • 1 Event
    • Alerta De Seguridad para Xhibit central station
Spacelabs fans
  • Modelo / Serial
    BLEASE 700 and BLEASE 900, referring to Pediatric Flow Sensors
  • Descripción del producto
    This equipment is used for the ventilation of adult and pediatric patients under general anesthesia.
  • Manufacturer
    Spacelabs Healthcare, Ltd.
  • 1 Event
    • Alerta De Seguridad para Spacelabs fans
multiparameter monitor for vital signs Ultraview SL Spacelabs
  • Modelo / Serial
    ULTRAVIEW SL 91496 with command modules with option A, B, C, I ", lots 128280, 129940, 129420 and 155640.
  • Descripción del producto
    Indicated for monitoring vital signs in patients in critical condition or observation. Use in hospital units (uci, surgery, emergencies, etc.) and ambulances.
  • Manufacturer
    Spacelabs Medical Inc
  • 1 Event
    • Alerta De Seguridad para multiparameter monitor for vital signs Ultraview SL Spacelabs
Multiparameter monitor Ultraview SL
  • Modelo / Serial
    91367, 91369, 91370, 91387 and 91393, specific serials.
  • Descripción del producto
    Indicated for monitoring vital signs in patients in critical condition or observation. Use in hospital units (Uci, Surgery, Emergency, etc.) and ambulances.
  • Manufacturer
    Spacelabs Medical Inc
  • 1 Event
    • Alerta De Seguridad para Multiparameter monitor Ultraview SL
Cardiocall event recorder
  • Modelo / Serial
    Models VS20, VS20x4, ST80 and ST80x4 and PCBA part number 670-1670-00, dispatched between December 23 || of 2014 and August 19, 2015
  • Descripción del producto
    This equipment has been designed and provided specifically for the monitoring of electrocardiograms activated by the patient. Indicated to record the electrocardiogram when a patient experiences intermittent transient symptoms such as dizziness, palpitations or shortness of breath, and this is able to activate the recorder in these sessions. The electrocardiogram is stored in memory.
  • Manufacturer
    Spacelabs Medical Inc.
  • 1 Event
    • Alerta De Seguridad para Cardiocall event recorder
Elance Model 93300 Monitoring Monitors
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Spacelabs
  • 1 Event
    • Retiro De Equipo (Recall) de Elance Model 93300 Monitoring Monitors
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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.