NOVALIS TX 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
    130306
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-06-29
  • 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 identified whereby following prolonged use the screw fastener holding the wedge body to the tray may fail. the falling wedge presents a risk of injury to patients or other personnel in the path of the falling wedge. the risk of failure is proportional to the amount of use of the wedge and is considered significant only after many years of use. the risk is also increased for heavier wedges upper wedges used in the interface mount and for wedges where the screw fasteners are loose or have a history of becoming loose. varian is aware of this occuring only for 30 degree upper wedges. other wedges may potentially be susceptible to the same failure.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: (Lot serial: Contact Manufacturer.); Model Catalog: (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: Contact Manufacturer.)
  • 제품 설명
    NOVALIS TX LINEAR ACCELERATOR
  • Manufacturer

Manufacturer