Events

Eclipse™ Treatment Planning System 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
    2012-03-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120320c.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
    Field safety notice: varian eclipse™ treatment planning system medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning eclipse™ treatment planning system, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0. according to varian, an anomaly has been identified with the eclipse™ treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. the issue may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution. varian is notifying all possibly affected customers with a field safety notice. according to varian, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Eclipse™ Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Varian FastPlan treatment planning system
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems