SOMATOM Force with software version VA50A 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-2017-RN-00487-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-19
  • 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
    An addendum is to be added to the instructions for use (ifu) of the somatom force system with software version va50a which is related to the use of the turbo flash mode with very short scan ranges. when selecting the turbo flash mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. as a workaround the addendum states for the turbo flash mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead.
  • 조치
    Siemens is advising users to always select a spiral scan length higher than 27mm or to switch to another mode when selecting the Turbo Flash Mode in combination with a spiral scan length of less than 27mm. (This information is contained in the addendum which will be posted to users). Users are requested to place this addendum in their User Manual and to disseminate the information to the relevant personnel at their organisation.

Device

  • 모델명 / 제조번호(시리얼번호)
    SOMATOM Force with software version VA50ACatalogue Number: 10742326ARTG Number: 274034
  • Manufacturer

Manufacturer