Events

ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for 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-2017-RN-01283-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-10-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01283-1
  • 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
    Elekta has become aware of the potential for incorrect dicom mapping of the exported collimator or couch angles from ergo. this would lead to incorrect rotation of the collimator or couch when using a mlc device for planning.If the dicom export values are not mapped correctly, it is possible that treatments could be delivered with the wrong collimator or couch angle. in the event patients were treated with the wrong collimator or couch angle, this would result in a geometric miss with the tumour being potentially under-dosed and normal structures overdosed.
  • 조치
    Elekta is advising users who are using MLC for dose planning in ERGO to run a verification test to ensure that the collimator and couch are rotating correctly. If the verification test fails please contact the Elekta Care Support Centre for assistance.

Device

ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning
  • 모델명 / 제조번호(시리얼번호)
    ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planningARTG Number: 187299
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd