MobileDiagnost wDR 1 and 2(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-2015-RN-00524-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-19
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behaviour may not be possible. the system can be stopped by releasing the drive handle. proper behaviour is re-enabled when the system is rebooted. the hazard associated to this defect is the potential of a collision.
  • 조치
    Philips is preparing a field action kit, which will allow a Philips Service Engineer to replace the existing arrestor strap by a new arrestor with higher resistivity. This will reduce the electromagnetic pulse to a level, which is safe to not disturb the electronics. Users are advised not to try to correct unintended movement using the controls on the drive handle. Instead, stop the system immediately by releasing the drive handle entirely. Alternatively, the emergency button can be pressed. Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur. This action has been closed-out on 18/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    MobileDiagnost wDR 1 and 2(Mobile digital x-ray imaging system)ARTG Number: 187112
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA