Events

Syngo X-Workplace with software version VD10E 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Siemens. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2016-03-16
  • 사례 출판 날짜
    2016-03-16
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160316.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: siemens syngo x-workplace with software version vd10e the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning syngo x-workplace with software version vd10e, manufactured by siemens. [catalogue numbers: 10094165, 10281299 and 10502522 when used in combination with carto systems]. according to the manufacturer, 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 cannot be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation. the manufacturer 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. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00267-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 16 march 2016.

Device

Syngo X-Workplace with software version VD10E
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Siemens Syngo X-Workplace with software version VD10E
  • Manufacturer
    Siemens.

Manufacturer

Siemens.