Events

Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    75078
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2886-2016
  • 사례 시작날짜
    2016-08-25
  • 사례 출판 날짜
    2016-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149576
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    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.
  • 조치
    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)
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
  • 제품 설명
    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
  • 제조사 주소
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA