Events

Monaco V 5.00 and higher (Radiation therapy treatment planning system software) 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-01493-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01493-1
  • 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
    Contours are not handled correctly if the ct dataset contains slices with dicom z coordinates of xx.X50mm. if the ct data contain slices that occur at positions of xx.X50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimisation and calculation of dose. unloading and reloading the patient data corrects the problem.Incorrect structure volumes can be used during optimisation. incorrect electron densities can be assigned to some regions of the patient.This can result in incorrect dose calculations. dose errors of greater than 5% can occur.
  • 조치
    This problem will be resolved in Monaco release 5.30 and in patches to Monaco releases 5.10 and 5.11. In the interim, the problem can be avoided if the user takes the following action: - Following contour edits, perform an “Unload All” and reload the plan prior to performing dose calculation. This action has been closed-out on 26/05/2017.

Device

Monaco V 5.00 and higher (Radiation therapy treatment planning system software)
  • 모델명 / 제조번호(시리얼번호)
    Monaco V 5.00 and higher (Radiation therapy treatment planning system software)ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd