Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model… recallZ-2886-2016 · Spacelabs Healthcare Inc · initiated Aug 25, 2016
Class II Terminated All recalls posted in September 2016
Is my device affected?
- 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.
- 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.
- 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-2886-2016
- 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
- 316 XTR units total (248 units in the US and 68 units outside US)
- Product code
- MHX
- FDA submissions
- K141156
- 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 Telemetry Receiver (XTR), Model 96280. 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 (4k characters)
Serial numbers of units distributed in the US 6280-000053, 6280-000056, 6280-000057, 6280-000058, 6280-000059, 6280-000066, 6280-000067, 6280-000068, 6280-000077, 6280-000078, 6280-000079, 6280-000083, 6280-000084, 6280-000085, 6280-000086, 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, 6280-000120, 6280-000121, 6280-000122, 6280-000123, 6280-000124, 6280-000125, 6280-000126, 6280-000127, 6280-000128, 6280-000129, 6280-000131, 6280-000132, 6280-000137, 6280-000138, 6280-000140, 6280-000141, 6280-000142, 6280-000143, 6280-000146, 6280-000147, 6280-000148, 6280-000149, 6280-000151, 6280-000152, 6280-000153, 6280-000154, 6280-000155, 6280-000156, 6280-000158, 6280-000159, 6280-000160, 6280-000161, 6280-000167, 6280-000168, 6280-000170, 6280-000171, 6280-000172, 6280-000173, 6280-000174, 6280-000176, 6280-000177, 6280-000200, 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, 6280-000250, 6280-000251, 6280-000252, 6280-000253, 6280-000254, 6280-000255, 6280-000256, 6280-000257, 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, 6280-000301, 6280-000302, 6280-000303, 6280-000306, 6280-000307, 6280-000308, 6280-000310, 6280-000311, 6280-000312, 6280-000315, 6280-000316, 6280-000318, 6280-000319, 6280-000321, 6280-000322, 6280-000324, 6280-000326, 6280-000327, 6280-000328, 6280-000329, 6280-000332, 6280-000333, 6280-000334, 6280-000338, 6280-000341, 6280-000342, 6280-000343, 6280-000344, 6280-000345, 6280-000346, 6280-000347, 6280-000348, 6280-000349, 6280-000350, 6280-000351, 6280-000352, 6280-000353, 6280-000354, 6280-000355, 6280-000357, 6280-000358, 6280-000363, 6280-000364, 6280-000365, 6280-000366, 6280-000367, 6280-000368, 6280-000369, 6280-000370, 6280-000375, 6280-000376, 6280-000377, 6280-000378, 6280-000380, 6280-000381, 6280-000382, 6280-000383, 6280-000385, 6280-000386, 6280-000387, 6280-000388, 6280-000389, 6280-000390, 6280-000391, 6280-000392, 6280-000394, 6280-000395, 6280-000396, 6280-000397, 6280-000398, 6280-000399, 6280-000402, 6280-000403, 6280-000404, 6280-000407, 6280-000408, 6280-000409, 6280-000410, 6280-000411, 6280-000412, 6280-000413, 6280-000414, 6280-000415, 6280-000417, 6280-000418, 6280-000419, 6280-000420, 6280-000421, 6280-000423, 6280-000426, 6280-000427, 6280-000429, 6280-000430, 6280-000431, 6280-000432, 6280-000436, 6280-000437, 6280-000438, 6280-000439, 6280-000440, 6280-000455, 6280-000456, 6280-000457, 6280-000458, 6280-000459, 6280-000460, 6280-000461, 6280-000462, 6280-000463, 6280-000464, 6280-000465, 6280-000466, 6280-000467, 6280-000468, 6280-000475, 6280-000476. Serial numbers of units distributed 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, 6280-000190, 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, 6280-000317, 6280-000330, 6280-000331, 6280-000356, 6280-000362, 6280-000371, 6280-000372, 6280-000384, 6280-000400, 6280-000401, 6280-000406, 6280-000416, 6280-000424, 6280-000425, 6280-000433, 6280-000435, and 6280-000473.
Other devices under the same FDA submission
2 devices cleared under K141156 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Xhibit Telemetry ReceiverSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 recalls30 reports
- XTR 96280Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 75078).
- Z-2885-2016 · TerminatedSpacelabs 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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