Z-1502-2016Class II

The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s)...

Name: Z-1502-2016 The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s)...
Creator: Spacelabs Healthcare Inc
Published: 2016-03-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-03-28 / Terminated

FDA source

Spacelabs Healthcare Inc began a recall of The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor on 2016-03-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1502-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-08-22
Terminated: 2016-12-19
Recalling firm: GE Healthcare
Product: The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
FDA root cause: Other
Action: On March 28, 2016, a customer letter will be sent via priority service, return receipt requested, to all U.S. customers. On April 4, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs recommends that you brief your staff regarding the failure modes listed above. If you continue to use affected Telemetry Receiver(s), please note: **When there is a loss of signal, a signal loss alarm is generated and a triangular-shaped squelch waveform is displayed for any channel exhibiting signal loss. If unacknowledged, this alarm will escalate to medium priority after five minutes. After an additional five minutes, this alarm will escalate to high priority. This failure is usually transient. **When the XTR goes offline, all telemetry waveform(s) associated with the XTR will disappear from the Central Station and an offline message will appear in each telemetry waveform zone. This failure is not recoverable. Please circulate this notification to all persons affected by the information it contains and add a copy to the appropriate monitor user manual until such time as corrections have been implemented by Spacelabs. Spacelabs will contact you to schedule a convenient time for Spacelabs to update your Xhibit Telemetry Receivers at no cost. If you have any questions about this corrective action, please contact Spacelabs at 1-800-522-7025 and select 2 for Technical Support.
Quantity in commerce: 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)
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1502-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1502-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-15

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)