Z-2886-2016Class II

Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be...

Name: Z-2886-2016 Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be...
Creator: Spacelabs Healthcare Inc
Published: 2016-08-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-08-25 / Terminated / root cause: software

FDA source

Spacelabs Healthcare Inc began a recall of Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the... on 2016-08-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2886-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Posted: 2016-09-26
Terminated: 2017-03-13
Recalling firm: GE Healthcare
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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 tag: software
FDA 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 in commerce: 316 XTR units total (248 units in the US and 68 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2886-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2885-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-26
Z-2886-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-26

Product code MHX

K141156Class IISpacelabs Healthcare Telemetry ReceiverSpacelabs Healthcare / cleared 2014-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)