Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Varian Medical Systems Australasia 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-2012-RN-00652-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-07-02
  • 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
    A software anomaly has been identified with the eclipse treatment planning system where changing the prescription in a calculated vmat or rapidarc plan may lead to monitor units which do not reflect the new prescription. if the dose prescription of a vmat or rapidarc plan is changed after the initial dose volume optimisation, the monitor units and dose distribution may not reflect the intended prescription.
  • 조치
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

  • 모델명 / 제조번호(시리얼번호)
    Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11Multiple Serial Numbers affectedProduct Code: H48ARTG Number: 119983
  • Manufacturer

Manufacturer