Events

Recall of Spacelabs Medical Vital Signs Monitor, Model 91220

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55319
  • Event Risk Class
    Class 2
  • Event Number
    Z-3185-2011
  • Event Initiated Date
    2010-04-14
  • Event Date Posted
    2011-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90548
  • Notes / Alerts
    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.
  • Extra notes in the data
    Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MHZ
  • Reason
    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.
  • Action
    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
  • Model / 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.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Manufacturer Address
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA