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Spacelabs Healthcare Xhibit Central Station, Model 96102… recallZ-2885-2016 · Spacelabs Healthcare Inc · initiated Aug 25, 2016

Class II Terminated All recalls posted in September 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spacelabs Healthcare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-2885-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 25, 2016
Posted by the FDA
Sep 26, 2016
Recalling firm
Spacelabs Healthcare Inc
Quantity
798 units total (488 units in the US and 310 units outside US)
Product code
MHX
FDA submissions
K122146
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.

Product description

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 (models, lots, serial numbers)

Show the full code information (12k characters)

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.

Other devices under the same FDA submission

3 devices cleared under K122146 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 75078).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page