Spacelabs Healthcare Inc: 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.

Recall number

Z-2885-2016

Recalling firm

Spacelabs Healthcare Inc

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.

Status

Terminated

Initiated

2016-08-25

Posted

2016-09-26

Terminated

2017-03-13

Reason

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.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

["K122146"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3010157426

Firm city

Snoqualmie

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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