Events

Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging system) 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-2016-RN-00267-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-03-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00267-1
  • 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 issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and can't be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation.
  • 조치
    Siemens is advising users that a software upgrade will be performed as a permanent correction. Users are advised to stop using any segmentation result for export to the CARTO system until the software upgrade is performed. This action has been closed-out on 25/01/2017.

Device

Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based...
  • 모델명 / 제조번호(시리얼번호)
    Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging system)Catalogue Numbers: 10094165, 10281299 and 10502522 when used in combination with CARTO systemsARTG Number: 160940
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd