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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)

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  Class 2 Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR) see related information
Date Initiated by Firm August 25, 2016
Date Posted September 26, 2016
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-2886-2016
Recall Event ID 75078
510(K)Number K141156  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
For Additional Information Contact Technical Support
800-522-7025 Ext. 2
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MHX and Original Applicant = SPACELABS HEALTHCARE
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