Events

MobileDiagnost wDR (Mobile digital 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-00959-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00959-1
  • 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
    If the system drives over insulated flooring or carpeting and then over an un-insulated (earthed) point or electrically grounded section, an electrostatic discharge (esd) spark can cause the system’s digital motion control (dmc) board to malfunction, resulting in unintended movement of the system e.G., an increase in speed or a change of direction. the hazard associated to this defect is the potential of a collision with the system.
  • 조치
    Users are provided with temporary workaround solutions to prevent the failure mode from occurring and if it occurs to stop the system immediately by releasing the drive handle entirely or by pressing the emergency button. A Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented that will allow to electrically isolate the DMC board from its frame by replacing the existing stainless steel bolts and washers with plastic spacers and nylon screws. This action has been closed-out on 1/06/2016.

Device

MobileDiagnost wDR (Mobile digital x-ray imaging system)
  • 모델명 / 제조번호(시리얼번호)
    MobileDiagnost wDR (Mobile digital x-ray imaging system)All units affectedARTG Number: 187112
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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