SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force 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-01355-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-11-08
  • 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
    Siemens has identified a potential risk of unnecessary radiation exposure due to a software issue in the care dose4d algorithm implemented in specific siemens ct scanners. this relates to possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. potentially, the care dose4d software will select the maximum tube current for the uppermost part of the skull, thus leading to unnecessary radiation exposure. the described issue will not occur when using a lateral topogram instead of a p.A. or an a.P. topogram. accordingly, siemens strongly recommends using topograms in lateral position for all head scans.
  • 조치
    Siemens is advising users that the described issue will not occur when using a lateral topogram instead of a.p.a. or an a.p. topogram. Accordingly, Siemens strongly recommends using topograms in lateral position for all head scans. Siemens will be providing a software update as a permanent correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM ForceCatalogue Numbers: 7740769, 8098027, 10590000, 10430603 and 10742326ARTG Number: 274034
  • 의료기기 분류등급
  • Manufacturer

Manufacturer