Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty 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-2016-RN-00924-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-11
  • 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
    Due to an error in the 19" live display, image reproduction may fail in the examination room. the loss of image can only occur immediately after system start-up. this failure does not occur during normal operation or when the live image is displayed. only systems which use a live display (reference dshc1914-dc with part number 10656055) in the examination room are affected. live displays with other part numbers are not affected by this issue.
  • 조치
    Siemens is advising users that the system can continue to be used. A firmware upgrade will be implemented as a permanent correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system)Reference Number: DSHC1914-DCPart Number: 10656055ARTG Number: 273952
  • Manufacturer

Manufacturer