Events

Retiro De Equipo (Recall) de Spacelabs Medical Vital Signs Monitor, Model 91220

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Spacelabs Healthcare, Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55319
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3185-2011
  • Fecha de inicio del evento
    2010-04-14
  • Fecha de publicación del evento
    2011-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90548
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MHZ
  • Causa
    There have been reports that the spacelabs medical vital signs monitor, model 91220, will not power up with ac power and will no longer charge the batteries.
  • Acción
    SpaceLabs Healthcare sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 15, 2010, to all affected customers. International consignees were notified by e-mail on April 22, 2010, with the customer notification letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use the device until their monitors can be upgraded. Customers were asked to brief their staff about the possibility of the monitor failure to help prevent an adverse event from happening.

Device

Spacelabs Medical Vital Signs Monitor, Model 91220
  • Modelo / Serial
    SERIAL NUMBERS: 1220M000275, 1220M000538, 1220M000552, 1220M000781, 1220M000902, 1220M000908, 1220M000910, 1220M000915, 1220M000917, 1220M000918, 1220M000919, 1220M000923, 1220M000925, 1220M000927, 1220M000928, 1220M000929, 1220M000930, 1220M000931, 1220M000932, 1220M000934, 1220M000935, 1220M000937, 1220M000938, 1220M000940, 1220M000941, 1220M000943, 1220M000944, 1220M000945, 1220M000947, 1220M000949, 1220M000950, 1220M000952, 1220M000953, 1220M000954, 1220M000955, 1220M000956, 1220M000957, 1220M000958, 1220M000959, 1220M000960, 1220M000962, 1220M000963, 1220M000964, 1220M000966, 1220M000968, 1220M000971, 1220M000972, 1220M000973, 1220M000974, 1220M000975, 1220M000977, 1220M000979, 1220M000980, 1220M000981, 1220M000982, 1220M000984, 1220M000985, 1220M000995, 1220M000996, 1220M000997, 1220M000999, 1220M001000, 1220M001001, 1220M001002, 1220M001003, 1220M001004, 1220M001005, 1220M001006, 1220M001007, 1220M001008, 1220M001009, 1220M001010, 1220M001013, 1220M001014, 1220M001015, 1220M001016, 1220M001017, 1220M001018, 1220M001020, 1220M001022, 1220M001023, 1220M001024, 1220M001025, 1220M001026, 1220M001028, 1220M001050, 1220M001051, 1220M001055, 1220M001056, 1220M001057, 1220M001059, 1220M001060, 1220M001061, 1220M001063, 1220M001064, 1220M001065, 1220M001066, 1220M001068, 1220M001069, 1220M001070, 1220M001071, 1220M001072, 1220M001075, 1220M001076, 1220M001078, 1220M001079, 1220M001080, 1220M001081, 1220M001083, 1220M001084, 1220M001085, 1220M001087, 1220M001088, 1220M001090, 1220M001091, 1220M001092, 1220M001093, 1220M001096, 1220M001099, 1220M001100, 1220M001101, 1220M001102, 1220M001103, 1220M001104, 1220M001106, 1220M001127, 1220M001128, 1220M001129, 1220M001130, 1220M001131, 1220M001132, 1220M001133, 1220M001134, 1220M001135, 1220M001136, 1220M001137, 1220M001138, 1220M001141, 1220M001142, 1220M001143, 1220M001145, 1220M001147, 1220M001148, 1220M001149, 1220M001151, 1220M001152, 1220M001154, 1220M001155, 1220M001156, 1220M001158, 1220M001162, 1220M001163, 1220M001164, 1220M001165, 1220M001166, 1220M001169, 1220M001171, 1220M001172, 1220M001173, 1220M001183, 1220M001184, 1220M001185, 1220M001186, 1220M001187, 1220M001188, 1220M001189, 1220M001190, 1220M001191, 1220M001192, 1220M001193, 1220M001194, 1220M001195, 1220M001196, 1220M001197, 1220M001198, 1220M001199, 1220M001200, 1220M001201, 1220M001202, 1220M001204, 1220M001205, 1220M001206, 1220M001207, 1220M001208, 1220M001209, 1220M001210, 1220M001211, 1220M001212, 1220M001213, 1220M001215, 1220M001216, 1220M001217, 1220M001218, 1220M001220, 1220M001221, 1220M001222, 1220M001223, 1220M001224, 1220M001225, 1220M001226, 1220M001227, 1220M001229, 1220M001232, 1220M001233, 1220M001234, 1220M001235, 1220M001236, 1220M001237, 1220M001238, 1220M001239, 1220M001240, 1220M001241, 1220M001242, 1220M001243, 1220M001244, 1220M001245, 1220M001246, 1220M001247, 1220M001248, 1220M001249, 1220M001250, 1220M001251, 1220M001252, 1220M001253, 1220M001254, 1220M001255, 1220M001256, 1220M001257, 1220M001258, 1220M001260, 1220M001261, 1220M001262, 1220M001263, 1220M001264, 1220M001265, 1220M001266, 1220M001267, 1220M001268, 1220M001269, 1220M001270, 1220M001271, 1220M001272, 1220M001273, 1220M001274, 1220M001275, 1220M001276, 1220M001277, 1220M001278, 1220M001279, 1220M001280, 1220M001285, 1220M001290, 1220M001297, 1220M001298, 1220M001299, 1220M001302, 1220M001303, 1220M001305, 1220M001306, 1220M001307, 1220M001308, 1220M001309, 1220M001310, 1220M001312, 1220M001313, 1220M001314, 1220M001315, 1220M001317, 1220M001318, 1220M001319, 1220M001320, 1220M001321, 1220M001322, 1220M001323, 1220M001324, 1220M001325, 1220M001326, 1220M001327, 1220M001328, 1220M001329, 1220M001330, 1220M001331, 1220M001332, 1220M001333, 1220M001334, 1220M001335, 1220M001336, 1220M001338, 1220M001339, 1220M001340, 1220M001341, 1220M001342, 1220M001343, 1220M001344, 1220M001345, 1220M001346, 1220M001347, 1220M001348, 1220M001349, 1220M001350, 1220M001351, 1220M001352, 1220M001353, 1220M001354, 1220M001355, 1220M001356, 1220M001357, 1220M001358, 1220M001359, 1220M001360, 1220M001361, 1220M001362, 1220M001363, 1220M001364, 1220M001365, 1220M001366, 1220M001368, 1220M001369, 1220M001370, 1220M001371, 1220M001372, 1220M001373, 1220M001374, 1220M001375, 1220M001376, 1220M001377, 1220M001378, 1220M001379, 1220M001380, 1220M001381, 1220M001382, 1220M001384, 1220M001385, 1220M001386, 1220M001387, 1220M001388, 1220M001389, 1220M001390, 1220M001391, 1220M001392, 1220M001395, 1220M001396, 1220M001397, 1220M001398, 1220M001400, 1220M001401, 1220M001402, 1220M001403, 1220M001404, 1220M001405, 1220M001406, 1220M001407, 1220M001408, 1220M001409, 1220M001410, 1220M001411, 1220M001412, 1220M001413, 1220M001414, 1220M001415, 1220M001416, 1220M001417, 1220M001418, 1220M001419, 1220M001420, 1220M001421, 1220M001422, 1220M001423, 1220M001424, 1220M001425, 1220M001426, 1220M001427, 1220M001428, 1220M001429, 1220M001430, 1220M001431, 1220M001432, 1220M001433, 1220M001434, 1220M001435, 1220M001436, 1220M001437, 1220M001438, 1220M001439, 1220M001440, 1220M001441, 1220M001442, 1220M001443, 1220M001444, 1220M001445, 1220M001446, 1220M001447, 1220M001448, 1220M001449, 1220M001450, 1220M001451, 1220M001452, 1220M001453, 1220M001454, 1220M001455, 1220M001456, 1220M001457, 1220M001458, 1220M001459, 1220M001460, 1220M001461, 1220M001462, 1220M001463, 1220M001464, 1220M001465, 1220M001466, 1220M001467, 1220M001468, 1220M001469, 1220M001470, 1220M001471, 1220M001472, 1220M001473, 1220M001474, 1220M001475, 1220M001476, 1220M001477, 1220M001478, 1220M001479, 1220M001480, 1220M001481, 1220M001482, 1220M001483, 1220M001484, 1220M001485, 1220M001486, 1220M001487, 1220M001488, 1220M001489, 1220M001490, 1220M001491, 1220M001492, 1220M001493, 1220M001494, 1220M001495, 1220M001496, 1220M001497, 1220M001499, 1220M001500, 1220M001501, 1220M001502, 1220M001503, 1220M001504, 1220M001505, 1220M001506, 1220M001507, 1220M001508, 1220M001509, 1220M001510, 1220M001511, 1220M001512, 1220M001514, 1220M001515, 1220M001516, 1220M001517, 1220M001518, 1220M001519, 1220M001520, 1220M001521, 1220M001522, 1220M001523, 1220M001524, 1220M001525, 1220M001526, 1220M001527, 1220M001528, 1220M001529, 1220M001530, 1220M001531, 1220M001532, 1220M001533, 1220M001534, 1220M001535, 1220M001536, 1220M001537, 1220M001538, 1220M001539, 1220M001540, 1220M001543, 1220M001544, 1220M001545, 1220M001546, 1220M001547, 1220M001548, 1220M001549, 1220M001550, 1220M001551, 1220M001552, 1220M001553, 1220M001554, 1220M001555, 1220M001556, 1220M001557, 1220M001558, 1220M001559, 1220M001560, 1220M001561, 1220M001562, 1220M001563, 1220M001564, 1220M001565, 1220M001566, 1220M001567, 1220M001568, 1220M001569, 1220M001570, 1220M001571, 1220M001572, 1220M001573, 1220M001574, 1220M001575, 1220M001576, 1220M001578, 1220M001579, 1220M001580, 1220M001581, 1220M001582, 1220M001583, 1220M001584, 1220M001585, 1220M001586, 1220M001587, 1220M001588, 1220M001589, 1220M001590, 1220M001591, 1220M001592, 1220M001593, 1220M001594, 1220M001595, 1220M001596, 1220M001597, 1220M001598, 1220M001599, 1220M001600, 1220M001601, 1220M001602, 1220M001603, 1220M001604, 1220M001605, 1220M001606, 1220M001607, 1220M001608, 1220M001609, 1220M001610, 1220M001611, 1220M001612, 1220M001613, 1220M001614, 1220M001615, 1220M001616, 1220M001617, 1220M001618, 1220M001619, 1220M001620, 1220M001621, 1220M001622, 1220M001623, 1220M001624, 1220M001625, 1220M001626, 1220M001627, 1220M001628, 1220M001629, 1220M001630, 1220M001631, 1220M001632, 1220M001633, 1220M001634, 1220M001635, 1220M001636, 1220M001637, 1220M001638, 1220M001639, 1220M001640, 1220M001641, 1220M001642, 1220M001643, 1220M001644, 1220M001645, 1220M001646, 1220M001647, 1220M001648, 1220M001649, 1220M001650, 1220M001651, 1220M001652, 1220M001653, 1220M001654, 1220M001655, 1220M001656, 1220M001658, 1220M001659, 1220M001660, 1220M001719, 1220M001720, 1220M001721, 1220M001722, 1220M001723, 1220M001724, 1220M001725, 1220M001726, 1220M001727, 1220M001728, 1220M001729, 1220M001730, 1220M001731, 1220M001732, and 1220M001742.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of UNITED ARAB EMIRATES, ARGENTINA, AUSTRALIA, BELGIUM, BAHRAIN, BRAZIL, CANADA, CHINA, COLOMBIA, GERMANY, ECUADOR, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, JORDAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, MALAYSIA, OMAN, POLAND, PUERTO RICO, PARAGUAY, ROMANIA, SAUDI ARABIA, SINGAPORE, SYRIAN ARAB REPUBLIC, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and URUGUAY.
  • Descripción del producto
    The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. || The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Dirección del fabricante
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA