Events

DX-D 600 X-ray System, Versions below 3.6 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AGFA HealthCare Australia 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-01247-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-11-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01247-1
  • 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 unit is equipped with safety measures to ensure no movement can occur without user interaction. however, a customer complaint reported that during normal movement’s isolated cases of unintended overhead tube crane acceleration occurred.
  • 조치
    Users are advised that in the case of an accelerated movement, release the button/pedal immediately to stop the unit and notify their Agfa HealthCare service contact at once. Agfa Healthcare will be upgrading all full automatic and semi-automatic DX-D 600 devices to Version 3.6 to eliminate this issue. This action has been closed-out on 12/08/2016.

Device

DX-D 600 X-ray System, Versions below 3.6
  • 모델명 / 제조번호(시리얼번호)
    DX-D 600 X-ray System, Versions below 3.6All full automatic & semi-automatic devices below version 3.6ARTG Number: 173861
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia