Events

Rappel de Device Recall Spacelabs Healthcare Xhibit Central Station

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75078
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2885-2016
  • Date de mise en oeuvre de l'événement
    2016-08-25
  • Date de publication de l'événement
    2016-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149318
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    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.
  • 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

Device

Device Recall Spacelabs Healthcare Xhibit Central Station
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
  • Description du dispositif
    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.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Adresse du fabricant
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA