The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Spacelabs Healthcare Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: AL, AZ, CA, CO, CT, FL, ID, IN, KY, MI, MN, MO, MS, MT, SC, TX, WY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1502-2016
Related Recalls
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.