Events

ExacTrac 6.0.3 Patient Positioning System (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-2014-RN-00269-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00269-1
  • 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 multiple isocenters (multiple radiation treatment targets) within a single plan, if a specific workflow is used and certain variables relating the software timing and user interaction are met, exactrac v6.0.3 might position the patient to an unintended isocenter position.
  • 조치
    Brainlab is requesting end users to avoid using treatment plans with multiple isocenters. If a plan with multiple isocenters cannot be avoided always close the patient ExacTrac after treatment of one isocenter is finished and reload the patient plan before selecting the next isocenter. Also, make sure to always select only one isocenter of the plan in ExacTrac in between opening and closing the patient. Brainlab will release a software update to correct the issue. Thia action has been closed-out on 28/01/2016

Device

ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient posit...
  • 모델명 / 제조번호(시리얼번호)
    ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system)
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd