CLINAC IX HIGH ENERGY LINEAR ACCELERATOR 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
    95992
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-04-23
  • 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
    Under certain conditions photon beams in high energy clinacs may experience a gradual change in beam symmetry potentially reaching an asymmetry of up to approximately 7 % before interlock occurs. at maximum asymmetry this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam. the type of asymmetry normally results in a beam which is higher than desired on one side of the central axis lower on the other side and approximately correct at the central axis. asymmetry value as used here means the peak to peak (over to under) differences observed. therefore a maximum asymmetry of 7% will result in a dose deviation of no more than 3.5% at any point in the beam with a smaller deviation near the central axis of the beam. normally the central axis dose values represent the calibration point and are not affected.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: CLINAC IX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: TRILOGY (Lot serial: H294991); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: 2100C (Lot serial: H270838); Model Catalog: 2100C (Lot serial: H270544); Model Catalog: 2100C (Lot serial: H270823); Model Catalog: 2100C (Lot serial: H271161); Model Catalog: 2100C (Lot serial: H270708); Model Catalog: TRILOGY (Lot serial: H291166)
  • 제품 설명
    Clinac IX High Energy Linear Accelerator
  • Manufacturer

Manufacturer