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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Spacelabs Healthcare, Llc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0403-2013
Related Recalls
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.