TRILOGY 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
    113924
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-08-16
  • 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
    An anomaly has been found with the clinac trilogy novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size. some jaw carriers were manufactured with the incorrect metal alloy which can potentialy cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack the jaw would be able to move freely in the closed direction. in this case the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under -dose of the intended target volume.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: TRILOGY (Lot serial: H294674); Model Catalog: CLINAC IX (Lot serial: H294758); Model Catalog: CLINAC IX (Lot serial: H294684); Model Catalog: NOVALIS TX (Lot serial: H294751); Model Catalog: CLINAC IX (Lot serial: H294766); Model Catalog: CLINAC IX (Lot serial: H294683); Model Catalog: CLINAC IX (Lot serial: H294750); Model Catalog: CLINAC IX (Lot serial: H294675)
  • 제품 설명
    Trilogy High Energy Linear Accelerator
  • Manufacturer

Manufacturer