Events

DuraDiagnost X-ray System 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-2015-RN-00089-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00089-1
  • 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
    During recent evaluations of the philips duradiagnost x-ray system, philips have identified a potential issue that may affect the performance of the equipment under certain conditions. 1) if all six t-nuts which are used to mount the x-ray tube arm base to the carriage were not properly assembled, the tube arm assembly could fall. 2) if all eight t-nuts which are used to mount the wall stand detector carrier box and base were not properly assembled, the wall stand detector carrier assembly could fall. 3) if all eight t-nuts which are used to mount the table base and table top floating frame were not properly assembled, the table top could be floating.
  • 조치
    A Philips Service Engineer will conduct an inspection to determine if the equipment is affected by this issue. If it is determined that the tube arm and wall stand fixture are not in the correct position the equipment should cease to be used until the tube arm and wall stand fixture have been replaced. A new tube arm and wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future will be fitted. This action has been closed-out on 18/07/2016.

Device

DuraDiagnost X-ray System

Manufacturer

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