Events

Recall of Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75078
  • Event Risk Class
    Class 2
  • Event Number
    Z-2886-2016
  • Event Initiated Date
    2016-08-25
  • Event Date Posted
    2016-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149576
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    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.
  • 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

Device

Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
  • Product Description
    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.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Manufacturer Address
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA