CLINAC IX RADIO THERAPY DELIVERY SYSTEM 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
    132987
  • 사례 위험등급
    II
  • 사례 시작날짜
    2010-01-13
  • 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 was discovered in which under certain circumstances of control circuit adjustments and component failure a c-series clinac can beam on with an asymmetric electron beam which is undetected by the interlocks intended to prevent it. the anomaly can occur in the rare event a balance potentiometer in the electron programming pcb fails and the other circuit settings are such that the effect is not detected.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: 23EX (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: 2100C/D (Lot serial: >10 serial numbers.); Model Catalog: 2300C/D (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: Contact manufacturer.); Model Catalog: 2100C/D (Lot serial: Contact manufacturer.); Model Catalog: 2300C/D (Lot serial: Contact manufacturer.); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: TRILOGY (Lot serial: H293787)
  • 제품 설명
    Clinac IX Radiotherapy Delivery System
  • Manufacturer

Manufacturer