Events

Monaco RTP System (Radiation 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-2013-RN-00708-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00708-1
  • 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
    This issue affects monaco releases that have been upgraded to 3.20.00 (from 3.10.00) and 3.30.00 (from 3.20.00) and a sample couch parameter file has been edited and saved prior to the upgrade. if the sample couch parameter files are edited (post upgrade), the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. if these changes are saved under the original name, when a software upgrade is loaded, the modified couch densities in these sample files will be overwritten with the default value of 1.000.
  • 조치
    Elekta is providing work around instructions for users to follow as an interim measure, Elekta is currently working on a preventative action, and will provide further information once this has been determined.

Device

Monaco RTP System (Radiation Treatment Planning System Software)
  • 모델명 / 제조번호(시리얼번호)
    Monaco RTP System (Radiation Treatment Planning System Software) Release 3.20.00 and 3.30.00 upgraded from 3.10.00 or 3.20.00 ARTG Number: 186856
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd