Events

Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Co. Phillips 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
    48992
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2210-2010
  • 사례 시작날짜
    2008-06-26
  • 사례 출판 날짜
    2010-08-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72469
  • 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
    Motorized Height Ceiling Suspension - Product Code IZI
  • 원인
    Monitor ceiling carriage may separate from the monitor ceiling suspension.
  • 조치
    On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.

Device

Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems
  • 모델명 / 제조번호(시리얼번호)
    Products are identified as Equipment numbers:  13046, 25934, 34702, 38592, 41455, 44791, 45059, 52463, 62671, 82824, 83667, 85095, 85137, 85190, 85195, 86189, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101036, 101077, 101612, 101952, 102664, 103147, 103238, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104497, 104670, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 105960, 203880, 215045, 215140, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505064, 505077, 505111, 505111, 505252, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505858, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506778, 519115, 519118, 519136, 519195, 519196, 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States and Canada.
  • 제품 설명
    Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. || Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • 제조사 주소
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA