The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient...
FDA Device Recall #Z-1502-2016 — Class II — March 28, 2016
Recall Summary
| Recall Number | Z-1502-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 28, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Spacelabs Healthcare Inc |
| Location | Snoqualmie, WA |
| Product Type | Devices |
| Quantity | 217 units of XTRs and 531 units of PCBAs (164 XTRs and 425 PCBAs in US and 53 XTRs and 106 PCBAs outside the US) |
Product Description
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Reason for Recall
Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored.
Distribution Pattern
distributed in AL, AZ, CA, CO, CT, FL, ID, IN, KY, MI, MN, MO, MS, MT, SC, TX, WY and in the following countries: AUSTRALIA, CANADA, CHINA, FRANCE, NETHERLANDS, PHILIPPINES, ROMANIA, and UNITED KINGDOM.
Lot / Code Information
Affected PCBAs have no serial numbers. Below is the Part Numbers: 040-1736-00 KIT,UPGRADE,PCBA,QUAD RCVR,T BAND, 96280; 050-0758-00 REPLACEMENT KIT, PCBA,QUAD RCVR, Q BAND, 96280; 050-0759-00 REPLACEMENT KIT, PCBA,QUAD RCVR, T BAND, 96280; 050-0760-00 REPLACEMENT KIT, PCBA,QUAD RCVR, V BAND, 96280; 050-0758-00-X REPLACEMENT KIT, PCBA,QUAD RCVR, Q BAND, 96280 EXCHANGE; 050-0759-00-X REPLACEMENT KIT, PCBA,QUAD RCVR, T BAND, 96280 EXCHANGE; 050-0760-00-X REPLACEMENT KIT, PCBA,QUAD RCVR, V BAND, 96280 EXCHANGE; 050-0519-00 CM KIT,ET,600 MHZ-1400MHZ,NA, 96280; 050-0532-00 CM KIT,ET,400MHZ-600MHZ,INTERNATIONAL, 96280. **************************SERIAL NUMBERS OF XTRs IN THE US************ 6280-000051, 6280-000053, 6280-000056, 6280-000057, 6280-000058, 6280-000059, 6280-000066, 6280-000067, 6280-000068, 6280-000077, 6280-000078, 6280-000079, 6280-000080, 6280-000083, 6280-000084, 6280-000085, 6280-000086, 6280-000087, 6280-000088, 6280-000090, 6280-000092, 6280-000093, 6280-000095, 6280-000096, 6280-000097, 6280-000098, 6280-000099, 6280-000100, 6280-000101, 6280-000102, 6280-000103, 6280-000104, 6280-000105, 6280-000106, 6280-000107, 6280-000108, 6280-000109, 6280-000110, 6280-000111, 6280-000112, 6280-000113, 6280-000114, 6280-000115, 6280-000116, 6280-000117, 6280-000118, 6280-000119, 6280-000120, 6280-000121, 6280-000122, 6280-000123, 6280-000124, 6280-000125, 6280-000126, 6280-000127, 6280-000128, 6280-000129, 6280-000131, 6280-000132, 6280-000133, 6280-000135, 6280-000136, 6280-000137, 6280-000138, 6280-000140, 6280-000141, 6280-000142, 6280-000143, 6280-000145, 6280-000146, 6280-000147, 6280-000148, 6280-000149, 6280-000151, 6280-000152, 6280-000153, 6280-000154, 6280-000155, 6280-000156, 6280-000157, 6280-000158, 6280-000159, 6280-000160, 6280-000161, 6280-000167, 6280-000168, 6280-000169, 6280-000170, 6280-000171, 6280-000172, 6280-000173, 6280-000174, 6280-000175, 6280-000176, 6280-000177, 6280-000200, 6280-000227, 6280-000228, 6280-000229, 6280-000233, 6280-000234, 6280-000235, 6280-000236, 6280-000238, 6280-000239, 6280-000240, 6280-000241, 6280-000242, 6280-000243, 6280-000245, 6280-000248, 6280-000250, 6280-000251, 6280-000252, 6280-000253, 6280-000254, 6280-000255, 6280-000256, 6280-000257, 6280-000259, 6280-000260, 6280-000261, 6280-000263, 6280-000264, 6280-000265, 6280-000266, 6280-000267, 6280-000268, 6280-000269, 6280-000271, 6280-000272, 6280-000273, 6280-000274, 6280-000275, 6280-000278, 6280-000279, 6280-000280, 6280-000281, 6280-000283, 6280-000284, 6280-000285, 6280-000286, 6280-000287, 6280-000288, 6280-000289, 6280-000298, 6280-000299, 6280-000301, 6280-000302, 6280-000303, 6280-000304, 6280-000306, 6280-000307, 6280-000308, 6280-000309, 6280-000310, 6280-000311, 6280-000312, 6280-000313, 6280-000314, 6280-000315, 6280-000316, 6280-000319, and 6281-000144. *********SERIAL NUMBERS OF XTRs OUTSIDE THE US************ 6280-000048, 6280-000050, 6280-000052, 6280-000060, 6280-000061, 6280-000062, 6280-000063, 6280-000064, 6280-000065, 6280-000076, 6280-000094, 6280-000178, 6280-000179, 6280-000181, 6280-000182, 6280-000183, 6280-000184, 6280-000185, 6280-000186, 6280-000188, 6280-000189, 6280-000190, 6280-000191, 6280-000193, 6280-000194, 6280-000195, 6280-000196, 6280-000197, 6280-000198, 6280-000199, 6280-000202, 6280-000225, 6280-000226, 6280-000231, 6280-000232, 6280-000237, 6280-000246, 6280-000247, 6280-000249, 6280-000262, 6280-000270, 6280-000276, 6280-000282, 6280-000290, 6280-000291, 6280-000292, 6280-000293, 6280-000294, 6280-000295, 6280-000297, 6280-000300, 6280-000305, and 6280-000317.
Other Recalls from Spacelabs Healthcare Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0532-2018 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver,... | Jan 17, 2018 |
| Z-0332-2017 | Class II | Xhibit Central Station, Model 96102. Inten... | Oct 18, 2016 |
| 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 |
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.