Events

MobileDiagnost wDR (mobile x-ray unit) 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-2013-RN-00034-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-01-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00034-1
  • 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
    Due to a potential electrical defect, encoder defect or software error the movement speed regulation of the mobilediagnost wdr does not work as intended. the device may move with increasing speed and/or in the wrong direction for up to 1.5 seconds after releasing the dead man switch (handle bar). additionally, there is the potential for batteries to overheat.
  • 조치
    Philips is advising customers to activate the emergency switch in the event of unintended movement which will immediately stop the MobileDiagnost wDR. Once a corrective action has been determined Philips will implement a fix to stop unintended movement. In addition, Philips will install a battery thermostat to the device.

Device

MobileDiagnost wDR (mobile x-ray unit)

Manufacturer

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