MONACO 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ELEKTA 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
    144084
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-08-16
  • 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
    In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session it is possible that the deleted contours are still present which would not be the intent of the planner. if the patient is not saved and recalled in a subsequently created plan the bev will show the contours as still present while the transverse sagittal and coronal views will show the contours as deleted. the total volume of the structure reported in the dvh and the structure control will not match. if the study set is saved and reopened before plan creation the total volume of the structure reported in the dvh and the structure control will be corrected. a similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: MONACO (Lot serial: VERSION 3.1 AND HIGHER)
  • 제품 설명
    MONACO
  • Manufacturer

Manufacturer

  • 제조사 주소
    ATLANTA
  • 제조사 모회사 (2017)
  • Source
    HC