Class 2 Device Recall Spacelabs Medical Vital Signs Monitor, Model 91220

• Date Initiated by Firm: April 14, 2010
• Date Posted: September 12, 2011
• Recall Status: Terminated on September 12, 2011
• Recall Number: Z-3185-2011
• Recall Event ID: 55319
• 510(K)Number: K082045
• Product Classification: Monitor, physiological, patient (with arrhythmia detection or alarms - Product Code MHZ
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare, Incorporated; 5150 220th Ave Se; Issaquah WA 98029-6834
• For Additional Information Contact: Al Van Houdt; 425-657-7200 Ext. 5970
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Component design/selection
• 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.
• Quantity in Commerce: 614 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MHZ