Events

ExacTrac (Image guided radiation treatment therapy patient positioning system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Brainlab Australia 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-00314-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-04-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00314-1
  • 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
    When using a specific plan update workflow in combination with a non-brainlab treatment planning system (tps), there is a possibility in exactrac 5.X to generate an unintended blend of two initially separate plans of the same patient. if the anomaly occurs, the information displayed by exactrac under “external name” and “dicom patient coordinates” might not be correctly related to the information simultaneously displayed within the “image set reconstruction” picture and under “brainlab coordinates.” such a display of inconsistent positioning information might mislead the user when selecting a treatment plan / isocenter in exactrac for patient positioning. if not detected by the user, this might result in a patient and treatment target position at the linear accelerator that is different than intended. as a consequence, the treatment dose might be delivered to a region different from the intended target region.
  • 조치
    Brainlab is providing users with work around instructions and is implementing a permanent software fix to correct the problem.

Device

ExacTrac (Image guided radiation treatment therapy patient positioning system)
  • 모델명 / 제조번호(시리얼번호)
    ExacTrac (Image guided radiation treatment therapy patient positioning system)Version numbers 5.0, 5.0.1, 5.0.2 and 5.5, 5.5.1, 5.5.2 ARTG Number: 121226
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd