Events

MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record) 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-2017-RN-00836-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00836-1
  • 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
    The machine characterization (mac) file is instrumental to the correct operation of mosaiq and your elekta linac. elekta has become aware of the potential for incorrect characterization of couch values, which will lead to incorrect table movements when using couch move assistant (cma). if the mac file is set up incorrectly it is possible that table shifts can be made in the wrong direction.
  • 조치
    Elekta is requesting the following: 1. If you are using the Couch Move Assistant (CMA) feature in MOSAIQ , run the verification test(s) given in the Customer Letter to ensure that your table is operating correctly; 2. Users should only run the tests applicable to your clinical workflows on all of your Elekta linacs that are configured for CMA; 3. If the test(s) pass successfully, sign the Acknowledgement form and return the form to Elekta; and 4. If the test(s) fail contact your local Elekta Care Support Centre for assistance.

Device

MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information sys...
  • 모델명 / 제조번호(시리얼번호)
    MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)Elekta Reference Number: FCA-IMS-0024ARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd