Events

DX-D 100 (Mobile diagnostic x-ray generator) 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-2013-RN-00560-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00560-1
  • 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
    Some agfa healthcare customers have encountered sporadic unintended movement when driving the dx-d 100 mobile unit.
  • 조치
    The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop. Customers are advised in the case of unintended movement not try to correct the units’ movement via the drive handle but release the drive handle immediately to stop the unit. If unintended movement is experienced, cusotmers are requested to notify Agfa Service. Affected units are required to be taken out of operation for correction.

Device

DX-D 100 (Mobile diagnostic x-ray generator)
  • 모델명 / 제조번호(시리얼번호)
    DX-D 100 (Mobile diagnostic x-ray generator)ARTG number: 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia