MULTILEAF COLLIMATOR 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
    47235
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-05-16
  • 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
    Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with treatment field defined by brainlab m3 without an interlock being asserted. when a demountable brainlab m3 mlc is installed on a varian accelerator the use of two a-b switches is required to deploy the desired mlc. both switches must be set to the correct position prior to use. the first a-b switch box connects the mlc workstation to either the varian mlc controller or to the brainlab m3 controller. the second a-b switch box connects the clinac console to either the varian mlc controller or the brainlab m3 controller. this connection includes the mlc interlock used to inhibit radiation from the clinac accelerator. the mlc that is not selected on this a-b switch is disconnected from the interlock circuitry.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: MLC 52 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542533); Model Catalog: MLC 52 (Lot serial: H542533); Model Catalog: MILLENIUM 80 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542182); Model Catalog: MLC 52 (Lot serial: H542182)
  • 제품 설명
    MULTILEAF COLLIMATOR
  • Manufacturer

Manufacturer