Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central moni...
FDA Device Recall #Z-0332-2017 — Class II — October 18, 2016
Recall Summary
| Recall Number | Z-0332-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 18, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Spacelabs Healthcare Inc |
| Location | Snoqualmie, WA |
| Product Type | Devices |
| Quantity | 348 units (292 units in the US and 56 units outside the US) |
Product Description
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Reason for Recall
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
Distribution Pattern
Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
Lot / Code Information
Software version 1.1.5, Affected Serial Numbers in the US ************************************* ADDITIONAL FIVE UNITS ADDED: SLA0216F01796; SLA0216F01808; SLA1215F01638; SLA1215F01645; SLA1215F01652; SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0115F00955, SLA0115F00961, SLA0115F00968, SLA0115F00969, SLA0115F00972, SLA0115F00976, SLA0116F01718, SLA0116F01720, SLA0116F01722, SLA0214F00489, SLA0216F01807, SLA0216F01809, SLA0216F01813, SLA0216F01821, SLA0216F01824, SLA0216F01837, SLA0216F01840, SLA0216F01844, SLA0314F00534, SLA0314F00535, SLA0314F00540, SLA0314F00543, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00552, SLA0314F00561, SLA0314F00567, SLA0414F00568, SLA0414F00585, SLA0416F01850, SLA0416F01853, SLA0416F01857, SLA0416F01860, SLA0416F01875, SLA0416F01876, SLA0416F01883, SLA0416F01885, SLA0416F01889, SLA0416F01895, SLA0416F01923, SLA0516F01969, SLA0516F01970, SLA0516F01972, SLA0516F01974, SLA0516F01975, SLA0516F01976, SLA0516F01977, SLA0516F01978, SLA0516F01981, SLA0516F01982, SLA0516F01985, SLA0516F01986, SLA0516F01987, SLA0516F01992, SLA0516F02002, SLA0516F02005, SLA0614F00631, SLA0614F00654, SLA0615F01188, SLA0615F01194, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01213, SLA0615F01237, SLA0615F01238, SLA0615F01239, SLA0615F01240, SLA0615F01244, SLA0615F01248, SLA0615F01261, SLA0714F00678, SLA0714F00688, SLA0714F00694, SLA0714F00702, SLA0714F00703, SLA0715F01274, SLA0715F01310, SLA0715F01314, SLA0715F01325, SLA0715F01331, SLA0715F01334, SLA0715F01346, SLA0715F01347, SLA0716F02009, SLA0716F02011, SLA0716F02013, SLA0716F02015, SLA0716F02016, SLA0716F02017, SLA0716F02020, SLA0716F02021, SLA0716F02022, SLA0716F02028, SLA0716F02034, SLA0716F02042, SLA0716F02043, SLA0716F02044, SLA0716F02045, SLA0814F00713, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01391, SLA0815F01395, SLA0815F01397, SLA0815F01400, SLA0815F01402, SLA0815F01403, SLA0815F01404, SLA0815F01405, SLA0815F01406, SLA0815F01407, SLA0815F01408, SLA0815F01409, SLA0815F01412, SLA0815F01415, SLA0815F01418, SLA0815F01419, SLA0815F01424, SLA0816F02048, SLA0816F02050, SLA0816F02051, SLA0816F02052, SLA0816F02053, SLA0816F02054, SLA0816F02055, SLA0816F02056, SLA0816F02057, SLA0816F02058, SLA0816F02059, SLA0816F02060, SLA0816F02061, SLA0816F02062, SLA0816F02063, SLA0816F02065, SLA0816F02066, SLA0816F02067, SLA0816F02074, SLA0816F02075, SLA0816F02076, SLA0816F02077, SLA0816F02078, SLA0816F02081, SLA0816F02082, SLA0816F02083, SLA0816F02085, SLA0816F02087, SLA0816F02089, SLA0816F02091, SLA0816F02092, SLA0816F02093, SLA0816F02094, SLA0816F02095, SLA0816F02096, SLA0816F02097, SLA0816F02098, SLA0816F02099, SLA0816F02100, SLA0816F02101, SLA0816F02102, SLA0816F02103, SLA0816F02104, SLA0816F02105, SLA0816F02106, SLA0816F02107, SLA0915F01439, SLA0915F01442, SLA0915F01447, SLA0915F01451, SLA0915F01452, SLA0915F01457, SLA0915F01459, SLA0915F01462, SLA0915F01468, SLA0915F01474, SLA0915F01493, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01501, SLA0915F01503, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0916F02108, SLA0916F02110, SLA0916F02111, SLA0916F02112, SLA0916F02114, SLA0916F02115, SLA0916F02117, SLA0916F02121, SLA0916F02122, SLA0916F02123, SLA0916F02126, SLA0916F02127, SLA0916F02130, SLA0916F02131, SLA0916F02132, SLA0916F02133, SLA0916F02134, SLA0916F02136, SLA0916F02137, SLA0916F02138, SLA0916F02139, SLA0916F02141, SLA0916F02142, SLA0916F02143, SLA0916F02145, SLA0916F02146, SLA0916F02147, SLA0916F02148, SLA0916F02149, SLA0916F02150, SLA0916F02153, SLA0916F02154, SLA0916F02155, SLA0916F02156, SLA0916F02158, SLA0916F02159, SLA0916F02160, SLA0916F02162, SLA0916F02163, SLA0916F02165, SLA0916F02166, SLA1015F01525, SLA1015F01528, SLA1015F01530, SLA1015F01540, SLA1015F01551, SLA1015F01560, SLA1114F00795, SLA1114F00820, SLA1115F01578, SLA1115F01579, SLA1115F01582, SLA1115F01584, SLA1115F01593, SLA1115F01594, SLA1115F01595, SLA1115F01596, SLA1115F01597, SLA1115F01599, SLA1115F01602, SLA1115F01603, SLA1115F01608, SLA1115F01609, SLA1214F00858, SLA1214F00871, SLA1214F00876, SLA1214F00881, SLA1214F00885, SLA1214F00886, and SLA1215F01632. ***********Affected Serial Numbers OUTSIDE the US ************************** SLA0114F00430, SLA0114F00437, SLA0114F00438, SLA0114F00439, SLA0114F00440, SLA0114F00443, SLA0115F00975, SLA0116F01724, SLA0314F00528, SLA0314F00541, SLA0414F00596, SLA0416F01872, SLA0416F01877, SLA0416F01880, SLA0612F00235, SLA0715F01270, SLA0715F01271, SLA0715F01273, SLA0715F01283, SLA0715F01335, SLA0716F02023, SLA0716F02025, SLA0716F02029, SLA0716F02031, SLA0716F02035, SLA0716F02036, SLA0716F02037, SLA0716F02040, SLA0716F02041, SLA0716F02047, SLA0815F01431, SLA0816F02049, SLA0816F02064, SLA0816F02069, SLA0816F02070, SLA0816F02071, SLA0816F02072, SLA0816F02073, SLA0816F02079, SLA0816F02080, SLA0816F02084, SLA0816F02086, SLA0916F02109, SLA0916F02118, SLA0916F02119, SLA0916F02120, SLA0916F02128, SLA0916F02129, SLA0916F02140, SLA0916F02161, SLA1014F00776, SLA1113F00348, SLA1113F00368, SLA1115F01604, SLA1115F01605, and SLA1213F00389.
Other Recalls from Spacelabs Healthcare Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0532-2018 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver,... | Jan 17, 2018 |
| Z-2886-2016 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver ... | Aug 25, 2016 |
| Z-2885-2016 | Class II | Spacelabs Healthcare Xhibit Central Station, Mo... | Aug 25, 2016 |
| Z-2343-2016 | Class II | 91496 Ultraview SL Command Module, Options A, B... | Jul 1, 2016 |
| Z-1502-2016 | Class II | The Spacelabs Healthcare Xhibit Telemetry Recei... | Mar 28, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.