Class 2 Device Recall Spacelabs Healthcare Xhibit Central Station

• Date Initiated by Firm: August 25, 2016
• Date Posted: September 26, 2016
• Recall Status: Terminated on March 13, 2017
• Recall Number: Z-2885-2016
• Recall Event ID: 75078
• 510(K)Number: K122146
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
• Code Information: Serial numbers of units distributed in the US SLA0216F01822, SLA0216F01827, SLA0416F01924, SLA0516F01935, SLA0216F01771, SLA0216F01773, SLA0216F01784, SLA0216F01787, SLA0416F01897, SLA0416F01898, SLA0416F01899, SLA0416F01905, SLA0416F01909, SLA0416F01910, SLA0416F01911, SLA0416F01912, SLA0416F01914, SLA0416F01915, SLA0416F01916, SLA0416F01917, SLA0416F01918, SLA0416F01919, SLA0416F01920, SLA0516F01971, SLA0516F01995, SLA0314F00534, SLA0314F00535, SLA0314F00548, SLA0314F00561, SLA0314F00567, SLA0715F01310, SLA0814F00713, SLA1115F01593, SLA1115F01595, SLA1115F01596, SLA1115F01597, SLA1115F01602, SLA1115F01609, SLA0216F01806, SLA0216F01810, SLA0216F01817, SLA0216F01818, SLA0216F01832, SLA0216F01833, SLA0216F01835, SLA0216F01839, SLA0515F01104, SLA0515F01105, SLA0515F01107, SLA0515F01111, SLA0515F01115, SLA0515F01116, SLA0515F01119, SLA0515F01120, SLA0515F01121, SLA0515F01123, SLA0515F01129, SLA0515F01142, SLA0515F01144, SLA0515F01145, SLA0515F01146, SLA0515F01147, SLA0515F01148, SLA0515F01149, SLA0515F01150, SLA0515F01151, SLA0515F01152, SLA0515F01153, SLA0515F01154, SLA0515F01155, SLA0515F01156, SLA0515F01157, SLA0515F01158, SLA0716F02010, SLA0115F00919, SLA0115F00921, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0515F01106, SLA0515F01108, SLA0515F01143, SLA0715F01327, SLA0715F01328, SLA0715F01329, SLA0915F01439, SLA0915F01442, SLA0915F01447, SLA0915F01451, SLA0915F01452, SLA0915F01457, SLA0915F01459, SLA0915F01468, SLA0915F01474, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01501, SLA0915F01503, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0115F00926, SLA0115F00963, SLA0115F00964, SLA0115F00986, SLA0116F01711, SLA0214F00497, SLA0216F01796, SLA0216F01808, SLA0216F01811, SLA0216F01812, SLA0216F01834, SLA0216F01843, SLA0216F01845, SLA0516F01948, SLA0516F01950, SLA0516F01951, SLA1015F01536, SLA1015F01539, SLA1215F01636, SLA1215F01637, SLA1215F01638, SLA1215F01645, SLA1215F01646, SLA1215F01651, SLA1215F01652, SLA1215F01654, SLA1215F01657, SLA1215F01659, SLA1215F01695, SLA0715F01346, SLA0715F01347, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01391, SLA0815F01395, SLA0815F01397, SLA0815F01400, SLA0815F01402, SLA0815F01404, SLA0815F01405, SLA0815F01406, SLA0815F01407, SLA0815F01408, SLA0815F01409, SLA0815F01412, SLA0815F01415, SLA0815F01418, SLA0815F01419, SLA0815F01424, SLA0114F00458, SLA0214F00484, SLA0214F00486, SLA0214F00527, SLA0416F01856, SLA0516F01967, SLA0516F01969, SLA0516F01970, SLA0516F01972, SLA0516F01974, SLA0516F01975, SLA0516F01976, SLA0516F01977, SLA0516F01981, SLA0516F01982, SLA0516F01985, SLA0516F01986, SLA0516F01987, SLA0516F01992, SLA0516F01996, SLA0516F02002, SLA0516F02005, SLA0615F01232, SLA0116F01722, SLA0915F01462, SLA0915F01463, SLA0216F01842, SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0116F01718, SLA0116F01720, SLA0414F00568, SLA0414F00585, SLA1214F00858, SLA1214F00871, SLA0615F01254, SLA0615F01255, SLA0615F01256, SLA0615F01262, SLA0615F01263, SLA1113F00355, SLA1113F00356, SLA1113F00357, SLA1113F00358, SLA1113F00363, SLA1113F00364, SLA1113F00365, SLA0615F01237, SLA0615F01239, SLA1015F01540, SLA1015F01551, SLA0416F01870, SLA0715F01314, SLA0716F02030, SLA0815F01426, SLA0115F00917, SLA0115F00918, SLA0115F00923, SLA0115F00924, SLA0115F00961, SLA0115F00968, SLA0115F00969, SLA0115F00972, SLA0115F00976, SLA0314F00529, SLA0314F00530, SLA0314F00531, SLA0314F00532, SLA0314F00536, SLA0314F00537, SLA0314F00538, SLA0314F00540, SLA0314F00542, SLA0314F00543, SLA0314F00544, SLA0314F00546, SLA0314F00547, SLA0314F00549, SLA0314F00550, SLA0314F00552, SLA0314F00553, SLA0314F00556, SLA0314F00565, SLA0416F01889, SLA0416F01895, SLA0216F01823, SLA0216F01828, SLA1015F01537, SLA0915F01471, SLA0915F01475, SLA0615F01188, SLA0615F01194, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01213, SLA0416F01866, SLA0416F01869, SLA0416F01881, SLA0515F01124, SLA0515F01125, SLA0515F01127, SLA0515F01128, SLA0515F01133, SLA0515F01137, SLA0416F01913, SLA1015F01534, SLA0416F01923, SLA0715F01334, SLA1015F01525, SLA1015F01528, SLA1015F01530, SLA1015F01558, SLA1015F01560, SLA1015F01535, SLA0715F01316, SLA0715F01317, SLA0715F01326, SLA0614F00655, SLA0116F01702, SLA0216F01783, SLA0216F01791, SLA0216F01794, SLA1015F01544, SLA0116F01692, SLA0516F01944, SLA0516F01949, SLA0516F01952, SLA0516F01957, SLA0516F01958, SLA0516F01959, SLA0516F01960, SLA0516F01961, SLA0516F01963, SLA1115F01576, SLA0416F01901, SLA0416F01904, SLA0416F01908, SLA0715F01275, SLA0715F01279, SLA0216F01824, SLA0216F01807, SLA0216F01809, SLA0416F01850, SLA0416F01860, SLA0416F01875, SLA0216F01732, SLA0216F01797, SLA0216F01800, SLA0216F01801, SLA0216F01802, SLA0815F01394, SLA0115F00948, SLA0115F00950, SLA0315F01047, SLA0416F01874, SLA0515F01159, SLA0515F01160, SLA0515F01161, SLA0515F01162, SLA0515F01163, SLA0515F01164, SLA0515F01165, SLA0515F01166, SLA0515F01167, SLA0515F01168, SLA0515F01169, SLA0515F01170, SLA0515F01171, SLA0515F01172, SLA0515F01173, SLA0515F01174, SLA0515F01175, SLA0515F01176, SLA0515F01177, SLA0515F01178, SLA0515F01179, SLA0515F01180, SLA0515F01181, SLA0515F01182, SLA0515F01183, SLA0614F00618, SLA0614F00619, SLA0614F00623, SLA0614F00624, SLA0614F00625, SLA0614F00627, SLA0614F00628, SLA0614F00629, SLA0614F00631, SLA0614F00633, SLA0614F00635, SLA0614F00636, SLA0614F00637, SLA0614F00641, SLA0614F00642, SLA0614F00644, SLA0614F00645, SLA0614F00650, SLA0614F00654, SLA0615F01226, SLA0615F01229, SLA0615F01231, SLA0615F01233, SLA0615F01234, SLA0615F01235, SLA0615F01236, SLA0615F01246, SLA0615F01248, SLA0714F00678, SLA0714F00687, SLA0715F01323, SLA0715F01324, SLA0715F01325, SLA0815F01331, SLA0815F01403, SLA0714F00688, SLA0714F00694, SLA0714F00696, SLA0714F00702, SLA0714F00703, SLA0516F01934, SLA0516F01962, SLA0614F00638, SLA0115F00955, SLA0216F01837, SLA0216F01840, SLA0216F01844, SLA1214F00876, SLA1214F00881, SLA1214F00885, SLA1214F00886, SLA0116F01693, SLA0116F01700, SLA0116F01707, SLA0116F01721, SLA0116F01729, SLA0416F01855, SLA0416F01891, SLA0416F01896, SLA1215F01622, SLA1215F01623, SLA1215F01625, SLA1215F01627, SLA1215F01629, SLA1215F01644, SLA1215F01789, SLA0116F01691, SLA0116F01699, SLA0116F01703, SLA0216F01772, SLA0216F01774, SLA0216F01775, SLA0216F01776, SLA0216F01778, SLA0216F01779, SLA0216F01780, SLA0216F01803, SLA0416F01861, SLA0416F01862, SLA0416F01863, SLA0416F01879, SLA0516F01941, SLA0516F01942, SLA0516F01943, SLA0516F01946, SLA0516F01980, SLA0516F01984, SLA0615F01212, SLA1014F00755, SLA1014F00760, SLA1014F00762, SLA1014F00767, SLA1014F00772, SLA1014F00773, SLA1014F00774, SLA1014F00775, SLA1014F00778, SLA1014F00779, SLA1014F00782, SLA1115F01572, SLA0216F01813, SLA0216F01821, SLA0416F01853, SLA0416F01884, SLA0416F01907, SLA0516F01945, SLA0516F01965, SLA0814F00707, SLA1115F01590, SLA1115F01600, SLA1115F01607, SLA0214F00489, SLA0615F01240, SLA0615F01244, SLA0615F01261, SLA0915F01493, SLA0516F01936, SLA0516F01953, SLA0516F01954, SLA0715F01274, SLA0116F01714, SLA0116F01715, SLA0116F01725, SLA0116F01726, SLA0216F01768, SLA0216F01769, SLA0216F01770, SLA0216F01777, SLA0216F01781, SLA0216F01788, SLA0216F01804, SLA0216F01805, SLA0115F00931, SLA0115F00937, and SLA0515F01131. Serial Numbers of units distributed OUTSIDE the US SLA0114F00430, SLA0114F00431, SLA0114F00432, SLA0114F00433, SLA0114F00436, SLA0114F00437, SLA0114F00438, SLA0114F00439, SLA0114F00440, SLA0114F00443, SLA0114F00450, SLA0114F00459, SLA0115F00951, SLA0115F00975, SLA0116F01701, SLA0116F01723, SLA0116F01724, SLA0214F00496, SLA0214F00500, SLA0214F00502, SLA0214F00505, SLA0214F00507, SLA0214F00508, SLA0214F00513, SLA0214F00517, SLA0214F00519, SLA0214F00523, SLA0214F00526, SLA0216F01733, SLA0216F01793, SLA0216F01795, SLA0216F01798, SLA0216F01814, SLA0216F01815, SLA0216F01816, SLA0216F01820, SLA0216F01825, SLA0216F01830, SLA0216F01838, SLA0314F00528, SLA0314F00541, SLA0414F00578, SLA0414F00579, SLA0414F00580, SLA0414F00581, SLA0414F00582, SLA0414F00586, SLA0414F00587, SLA0414F00595, SLA0414F00596, SLA0414F00605, SLA0414F00606, SLA0414F00607, SLA0414F00608, SLA0414F00609, SLA0414F00611, SLA0414F00612, SLA0416F01849, SLA0416F01865, SLA0416F01868, SLA0416F01877, SLA0416F01878, SLA0416F01880, SLA0416F01882, SLA0416F01890, SLA0416F01892, SLA0416F01893, SLA0416F01906, SLA0416F01925, SLA0512F00183, SLA0512F00185, SLA0512F00186, SLA0512F00187, SLA0512F00188, SLA0512F00189, SLA0512F00190, SLA0512F00191, SLA0512F00192, SLA0512F00195, SLA0512F00196, SLA0512F00203, SLA0512F00208, SLA0512F00209, SLA0512F00211, SLA0516F01926, SLA0516F01927, SLA0516F01928, SLA0516F01929, SLA0516F01930, SLA0516F01931, SLA0516F01932, SLA0516F01937, SLA0516F01938, SLA0516F01939, SLA0516F01940, SLA0516F01947, SLA0516F01964, SLA0516F01997, SLA0612F00217, SLA0612F00219, SLA0612F00221, SLA0612F00223, SLA0612F00224, SLA0612F00226, SLA0612F00227, SLA0612F00228, SLA0612F00229, SLA0612F00230, SLA0612F00232, SLA0612F00233, SLA0612F00235, SLA0612F00236, SLA0612F00237, SLA0612F00238, SLA0612F00240, SLA0612F00241, SLA0612F00245, SLA0612F00248, SLA0612F00249, SLA0612F00251, SLA0612F00253, SLA0612F00255, SLA0612F00256, SLA0612F00263, SLA0612F00264, SLA0612F00266, SLA0612F00268, SLA0612F00272, SLA0612F00273, SLA0614F00647, SLA0615F01186, SLA0615F01189, SLA0615F01195, SLA0615F01203, SLA0615F01205, SLA0615F01206, SLA0615F01207, SLA0615F01208, SLA0615F01215, SLA0615F01216, SLA0615F01218, SLA0615F01220, SLA0615F01221, SLA0615F01222, SLA0615F01224, SLA0615F01225, SLA0615F01227, SLA0615F01228, SLA0615F01230, SLA0714F00667, SLA0714F00668, SLA0714F00669, SLA0714F00670, SLA0714F00671, SLA0714F00672, SLA0714F00673, SLA0714F00674, SLA0714F00675, SLA0714F00676, SLA0714F00677, SLA0714F00679, SLA0714F00680, SLA0714F00681, SLA0714F00682, SLA0714F00683, SLA0714F00684, SLA0714F00690, SLA0714F00691, SLA0714F00692, SLA0714F00693, SLA0714F00695, SLA0714F00697, SLA0714F00698, SLA0714F00699, SLA0714F00700, SLA0714F00701, SLA0714F00706, SLA0715F01270, SLA0715F01271, SLA0715F01273, SLA0715F01276, SLA0715F01277, SLA0715F01278, SLA0715F01281, SLA0715F01282, SLA0715F01283, SLA0715F01289, SLA0715F01292, SLA0715F01298, SLA0715F01299, SLA0715F01300, SLA0715F01303, SLA0715F01309, SLA0715F01311, SLA0715F01312, SLA0715F01318, SLA0715F01319, SLA0715F01320, SLA0715F01333, SLA0715F01335, SLA0715F01343, SLA0715F01344, SLA0715F01345, SLA0715F01368, SLA0716F02024, SLA0716F02025, SLA0716F02032, SLA0716F02046, SLA0814F00710, SLA0814F00716, SLA0814F00731, SLA0814F00742, SLA0814F00745, SLA0815F01417, SLA0815F01423, SLA0815F01428, SLA0815F01433, SLA0915F01441, SLA0915F01445, SLA0915F01454, SLA0915F01456, SLA0915F01464, SLA0915F01467, SLA0915F01480, SLA0915F01481, SLA0915F01484, SLA0915F01485, SLA0915F01486, SLA0915F01487, SLA0915F01488, SLA0915F01489, SLA0915F01492, SLA0915F01495, SLA0915F01515, SLA0915F01517, SLA1014F00754, SLA1014F00757, SLA1014F00759, SLA1014F00764, SLA1014F00766, SLA1014F00769, SLA1014F00770, SLA1014F00776, SLA1014F00777, SLA1014F00780, SLA1014F00787, SLA1014F00791, SLA1014F00792, SLA1014F00793, SLA1015F01523, SLA1015F01526, SLA1015F01533, SLA1015F01545, SLA1015F01549, SLA1015F01550, SLA1015F01561, SLA1113F00348, SLA1113F00360, SLA1113F00361, SLA1113F00368, SLA1113F00373, SLA1113F00382, SLA1114F00831, SLA1115F01573, SLA1115F01580, SLA1115F01585, SLA1115F01589, SLA1115F01591, SLA1115F01601, SLA1115F01604, SLA1115F01605, SLA1213F00386, SLA1213F00389, SLA1213F00390, SLA1213F00395, SLA1213F00396, SLA1213F00397, SLA1213F00399, SLA1213F00408, SLA1213F00413, SLA1213F00419, SLA1214F00838, SLA1214F00854, SLA1214F00863, SLA1214F00867, SLA1214F00875, SLA1214F00879, SLA1214F00880, SLA1214F00883, SLA1214F00888, SLA1214F00892, SLA1214F00895, SLA1214F00900, SLA1214F00901, SLA1214F00904, SLA1214F00913, SLA1214F00914, SLA1215F01621, SLA1215F01626, SLA1215F01628, SLA1215F01631, SLA1215F01633, SLA1215F01642, SLA1215F01647, SLA1215F01648, SLA1215F01653, SLA1215F01655, SLA1215F01658, SLA123F00393, and SLA515F01141.
• Recalling Firm/ Manufacturer: Spacelabs Healthcare Inc; 35301 SE Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: Technical Support; 800-522-7025 Ext. 2
• Manufacturer Reason for Recall: The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
• FDA Determined Cause: Software design
• Action: Spacelabs sent a letter dated August 25, 2016 to affected US consignees informing them of the going offline or locking up issue when Xhibit Central Station is used as part of an Xhibit Telemetry System. On September 1, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs sent the second Urgent - Medical Device Correction letter, dated September 15, 2016, to affected US consignees informing them that they have received reports of certain short-duration asystole alarms generated by the Xhibit Telemetry Receiver (XTR) where there may be no audible or visual alarm. On September 22, 2016, a second letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to update the recalled Xhibit Telemetry System at no cost. Customers with Xhibit Telemetry Receivers will get all Xhibit Central Stations updated regardless if connected to an Xhibit Telemetry Receiver. Consignees are directed to technical support for additional information or technical assistance: Technical Support Spacelabs Healthcare, Inc 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support
• Quantity in Commerce: 798 units total (488 units in the US and 310 units outside US)
• Distribution: Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
• 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 = MHX