Events

MobileDiagnost wDR (Mobile x-ray imaging 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-2014-RN-00565-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00565-1
  • 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
    The mobilediagnost wdr executes an unintended exposure under the following specific error conditions:- the hand switch is erroneously stuck in pressed position, while the system is switched off, - the system is powered up with the hand switch in that erroneous condition, - the user logs in, selects a patient for examination, gets a green ready light in, - the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure.The hazard associated to this defect is one single unintended exposure with the parameters configured previously by the user in the last examination. no continuous radiation is emitted in any case.
  • 조치
    Philips plans to update the software Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. The system can be used according to the Instruction for Use without restrictions. This action has been closed-out on 10/02/2016.

Device

MobileDiagnost wDR (Mobile x-ray imaging system)

Manufacturer

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