ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC) 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
    86960
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-05-03
  • 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
    It has been identified that in certain configurations the 4ditc can interpret a rapidarc or vmat treatment field as 3d conformal arc treatment plan. if a rapidarc or vmat treatment field is incorrectly interpreted as conformal arc the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery which can lead to delivered dose being different than planned. this will only happen when the change in mu / deg between consecutive control points is small. in other words it can only happen when the dose rate or gantry speeds vary in a very smooth and progressive way for the entire rapidarc field. rapidarc treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: V8.6 (Lot serial: >10 serial numbers.); Model Catalog: V8.8 (Lot serial: >10 serial numbers.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.8 (Lot serial: Contact manufacturer.)
  • 제품 설명
    Aria Practice Management 4D Integrated Treatment Console (4DITC)
  • Manufacturer

Manufacturer