Biograph mCT systems running the VG40A or VG40B software(Digital Imaging System) 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-2013-RN-00623-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-19
  • 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
    This recall action is an update to rc-2013-rn-00357-1.Siemens has identified that biograph mct systems running software vg40a or vg40b can experience intermittent aborting of ct or pet/ct scans during an examination, in addition to intermittent ct planning and image reconstruction failures. these issue are due to software errors.
  • 조치
    Siemens is advising end users on how a check can be performed during the planning of the CT acquisitions and reconstructions, within a PET/CT protocol that could indicate that a problem is likely to occur. The problems will be addressed in the upcoming VG40C software release which is planned to be released within the next 2 months.

Device

  • 모델명 / 제조번호(시리얼번호)
    Biograph mCT systems running the VG40A or VG40B software(Digital Imaging System)
  • Manufacturer

Manufacturer