Monaco V5.10 and V5.20 (used for radiation treatment planning) 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-01281-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-28
  • 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
    It has been identified that when running monaco v 5.10 or v 5.20 and creating 3d plans using either mu or dose weighting modes, if the user changes the physician's intent rx dose and the number of fractions, and then modifies the wedge angle, the monitor unit (mu) value is scaled incorrectly. the scaling of the mu is in direct proportion to the fractional change.If the mus are not correct, the patient will be incorrectly treated. there could be a critical overdose or underdose proportional to the fractional rescale. however, prior to treatment, independent dose calculation checks and secondary mu checks should always be done. both should be standards of practice in radiation therapy clinics and will detect the problem.
  • 조치
    Elekta is advising users that the issue is resolved with Monaco release 5.11.00 which is available now and with patches for versions 5.10 and 5.20. Elekta is also advising users that dose calculation checks and secondary MU checks should detect the problem, and that the problem can be avoided by forcing a Monaco recalculation (change dose calculation grid spacing and change back) when any wedge angle change is made.

Device

  • 모델명 / 제조번호(시리얼번호)
    Monaco V5.10 and V5.20 (used for radiation treatment planning) ARTG Number: 215960
  • Manufacturer

Manufacturer