Events

Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Varian Medical Systems 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
    2011-10-17
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111018.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
    Urgent field safety notice: eclipse™ electron monte carlo (emc) release 6.5 thru 8.9 (dcs build 7.5.Xx thru 8.0.Xx and dcf build 8.1.Xx thru 8.9.17), and eclipse release 10.0 (dcf build 10.0.25 and 10.0.28) medical device manufacturer, varian medical systems, issued an urgent field safety notice concerning eclipse emc release 6.5 thru 8.9 and eclipse release 10.0, due to the configuration of the eclipse emc algorithm with non-equidistant data points in the open air profile may lead to inaccurate results, which may result in incorrect dose in the lateral direction. varian is sending a notification letter to remind users of the necessary actions. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for the corrective actions.

Device

Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF bu...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28)
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems