ECLIPSE TPS V8.8 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
    51437
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-05-18
  • 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
    In eclipse the model for linear accelerator treatment head consists of both upper and lower jaws with an optional mlc. in the case of a treatment machine where the mlc replaces the lower moveable jaws (eg. siemens mlc and ge mlc) the lower jaw and mlc is represented in eclipse by combination of virtual jaws and an mlc. the calculation will treat the virtual jaw as a beam limiting device such that the resultant dose distribution will be bounded by the virtual jaw if it lies within the mlc aperture. when calculating or approving a treatment plan if a virtual jaw is positioned inside the mlc aperture a warning will be displayed in external beam planning task when planning for siemens mlc accelerator. this warning states that the virtual collimator jaws are positioned inside the mlc aperture a position which is not physically possible. this warning message is not displayed in case of other accelerator types without back up jaws (eg. ge saturne with ge mlc) or when irreg planning task is being used. if the user proceeds with the calculation the virtual jaws will remain in the current position and will be handled as a beam limiting device for the dose calculation. this will result in the region under the virtual jaw but within the mlc aperture showing no or low dose. treatment using such a plan will result in dose being delivered to the patient outside of the area indicated in the planned dose distribution and within the entire mlc aperture.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 100042024 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: TPA001075000 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: TPA001075000 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: 100042024 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: UP9001 (Lot serial: H481364); Model Catalog: UP9001 (Lot serial: H482173)
  • 제품 설명
    Eclipse Treatment Planning System V8.8
  • Manufacturer

Manufacturer