Events

Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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
    RC-2014-RN-00786-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-07-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00786-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    In the ingenia rear cover set magnetic m10 nuts (four) were erroneously supplied to the installer instead of non- magnetic a4 stainless steel nuts.
  • 조치
    All Philips installation and service engineers have been alerted to this hazard. A Field Change Order with reference FCO 78100432 is being released directing Philips field service engineers to inspect the Ingenia rear cover set nuts and replace them if needed with non-magnetic stainless steel nuts. Philips is instructing the customers to contact, if required with regard to this program, quoting the reference FCO 78100432. This action has been closed-out on 04/08/2016.

Device

Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA