ECLIPSE TPS V8.8 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS INC. 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
    27320
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-05-16
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    An anomaly has been identified with varian eclipse treatment planning system and aria radiation oncology (rt chart application) where adding a reference point in aria rt chart and editing the field dose contributions may change the prescribed dose per fraction in eclipse. a reference point added in aria rt chart does not have a location and is sometimes referred to as a "dose prescription volume" or dpv. if a reference point without location or dpv is added in aria rt chart and the field dose contribution of the reference point is edited this may cause the dose per fraction and total prescribed dose of an unapproved treatment plan in eclipse to change. this anomaly can occur when there is plan normalization such that the total done and the total dose at primary have different values.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 100042024 (Lot serial: >10 serial numbers.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.)
  • 제품 설명
    Eclipse Treatment Planning System V8.8
  • Manufacturer

Manufacturer