Events

ARTIS pheno systems 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-2018-RN-00667-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00667-1
  • 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
    Siemens is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm {1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
  • 조치
    As an immediate measure, Siemens' service organisation limits the maximum manual LAO/ RAO rotation from 25°/sec to 20°/sec and Cran/Caud rotation from 20°/sec to 10°/sec. All other system parameters as well as 3D acquisition and Perivis ion/Peristepping remain unaffected. Siemens are working on a solution to restore the system back to the original settings, and their service organisation will contact affected users to arrange an appointment to carry out the corrective action.

Device

ARTIS pheno systems
  • 모델명 / 제조번호(시리얼번호)
    ARTIS pheno systemsCatalogue Number: 10849000ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd