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U.S. Department of Health and Human Services

Class 2 Device Recall Qube Compact Monitor Model 91390

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 Class 2 Recall
Qube Compact Monitor Model 91390
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on May 22, 2013
Recall Number Z-0403-2013
Recall Event ID 63504
Premarket Notification
510(K) Number
K120616 
Product Classification Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah, Washington 98029-6834
For Additional Information Contact Global Tech Support
800-522-7025
Manufacturer Reason
for Recall
Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated October 19, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact Spacelabs Healthcare at 1-800522-7025 option 2 for questions regarding this notice.
Quantity in Commerce 742 total devices distributed; 530 with the U.S. and 212 Internationally.
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SPACELABS MEDICAL, INC.
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