Monaco software versions 5.10.00 and higher 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Elekta Pty Ltd 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
    RC-2016-RN-00651-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-05-25
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    When dicom is exporting a 3d monaco plan and the “composite field sequencing” (cfs) checkbox is selected, the y jaws will snap to the port shape when they should remain where they were defined. this occurs when the port shape used to define or edit the mlc positions extends beyond or inside the actual jaw positions. the defect is triggered when using a workflow for forward planning imrt that involves creating multiple beams for the same gantry angle with a single mlc shape defined for each beam. these beams are then exported using cfs to combine the individual 3d beams into a single imrt beam sequence. the planned and approved dose distribution will not agree with the dose delivered. this deviation is considered as a geometric miss and the patient can be overdosed or under dosed depending on whether the mlc shape is drawn outside or inside of the collimator jaws. there is a remote probability that serious injury could occur.
  • 조치
    Elekta is advising users to avoid using the CFS option for any 3D delivery mode plan, including Forward IMRT based plans. A software correction will be implemented as a permanent correction. This action has been closed-out on 09/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Monaco software versions 5.10.00 and higherARTG Number: 215960
  • 의료기기 분류등급
  • Manufacturer

Manufacturer