SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012B 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2012-RN-01298-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-01-08
  • 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
    There is a sporadic malfunction concerning 3d reconstructions during activated "preview image" functionality. the problem may occur during the process of 3d recon job planning and editing within the "examination" card while the "preview image" functionality is activated; when switching then to another recon job the system might sporadically hang up.
  • 조치
    The customer letter identifies the software workarounds to mitigate the problems temporarily. Siemens will schedule software upgrades shortly for mitigating the problems permanently.

Device

  • 모델명 / 제조번호(시리얼번호)
    SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012BARTG Number: 164065
  • Manufacturer

Manufacturer