Events

SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral" 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-2015-RN-01057-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01057-1
  • 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 use of the combination phs1600 table with the perfusion scan mode 'adaptive 4d spiral' (typically used for critical diagnostic examinations) could occasionally initiate scan aborts. there is an increased risk of a scan abort when using the perfusion scan mode in combination with the phs1600 table, especially when applying contrast media. please note that the decreased performance stability is not affecting any other scan modes or the mechanical stability of the table in general.
  • 조치
    Siemens is developing a solution for the use of the patient table PHS1600 in combination with the "Adaptive 40 Spiral" scan mode. Users are advised that they should be aware of the increased risk of a scan abort while using the perfusion scan mode in combination with the PHS1600 table. This action has been closed-out on 31/08/2016.

Device

SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D ...
  • 모델명 / 제조번호(시리얼번호)
    SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"ARTG Number: 164065
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd