Events

SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic computed tomography 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-00950-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00950-1
  • 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 have identified that when using the affected devices with software version va48a-sp2, problems can occur with the contrast agent injectors, regardless of the brand of injector involved. due to an internal communication error between the firmware and the software of the components involved, the planned ct scan is properly executed, however the injector is not started. this affects only the automatic mode, which is also called the "coupled mode", i.E. does not concern the manual control of the injector. as a result of this error, the contrast agent is not injected and the desired examination result is not achieved.
  • 조치
    Siemens is advising users to stop using the automatic "coupled mode", and to only use control manually. Siemens will be implementing a firmware correction as a permanent fix. This action has been closed-out on 22/02/2017.

Device

SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast age...
  • 모델명 / 제조번호(시리얼번호)
    SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic computed tomography x-ray system)ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd