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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280

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 Class 2 Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280see related information
Date Initiated by FirmMarch 28, 2016
Create DateAugust 22, 2016
Recall Status1 Terminated 3 on December 19, 2016
Recall NumberZ-1502-2016
Recall Event ID 73634
510(K)NumberK141156 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductThe Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
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.
FEI Number 3010157426
Recalling Firm/
Manufacturer		 Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
For Additional Information ContactTechnical Support
800-522-7025 Ext. 2
Manufacturer 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 Determined
Cause 2		Other
ActionOn 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 Commerce217 units of XTRs and 531 units of PCBAs (164 XTRs and 425 PCBAs in US and 53 XTRs and 106 PCBAs outside the US)
Distributiondistributed 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MHX
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