SOMATOM go.Up and SOMATOM go.Now 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-2018-RN-00377-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-01
  • 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 that the following issues with somatom go.Up and somatom go.Now may require an additional scan that exposes the patient to an additional x-ray dose: 1: software stability problems preventing the start of a reconstruction after the ct examination. if these problems occur, this is indicated by a red cross in the “job status” table. 2: impact on image quality: if the detector is still in adjustment mode at the time the scan command is provided from the control box, severe streak artefacts may occur. 3: only for customers using syngo osteo ct: if the scan/recon tab card is closed after an osteoporosis scan of a patient but before the intended osteo reconstruction has been completed, the osteo reconstruction cannot be continued or completed at a later point in time. in this case, a rescan would be necessary to complete the osteo reconstruction.
  • 조치
    Siemens is advising that the stability and quality issues are solved by the software updates VA10A_SP2 and VA20A. The Osteo reconstruction issue is solved with the VA20A software update. Siemens will be informing users as soon as the update(s) are available for their systems. In the interim, users should refer to the information provided in the Customer Letter for an Operator workaround for the issues identified.

Device

  • 모델명 / 제조번호(시리얼번호)
    SOMATOM go.Up and SOMATOM go.NowCatalogue numbers: 11061628 and 11061618ARTG number: 142119(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer

Manufacturer