Events

SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic 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-01433-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01433-1
  • 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 small light marker window used for the positioning laser and integrated in the front cover of the ct that had loosened in the past and had been subsequently fixed, could now become loose again and potentially drop out. in this case, there is a risk that a person could touch rotating or electrical parts of the gantry when reaching through the window opening. there is a risk for serious injury e.G. by electrical shock or physical harm to fingers.
  • 조치
    Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.

Device

SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
  • 모델명 / 제조번호(시리얼번호)
    SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)Catalogue Numbers: 8098027, 10430603ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd