Events

CombiDiagnost R90 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems DMC GmbH 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
    22314
  • 사례 시작날짜
    2017-11-24
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    The manufacturer has become aware that in some combidiagnost deliveries the tube adapter-plate green/yellow protective earthing wire was removed, during gcf tubes assembly, spacers with different thickness are used to position pre-loc ring in respect to focal spot in specified distance., there is a potential of an electrical shock if following factors occurs:, 1. an electrical failure leads to an electrical potential on the adapter plate, 2. the earth resistance based on mechanical connection is beyond limit, 3. person removes the tube cover. (not allowed for the customer), 4. person touches the live wired part during exposure/fluoroscopy.
  • 조치
    Product to be modified

Device

CombiDiagnost R90

Manufacturer

Philips Medical Systems DMC GmbH
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA