Events

HexaPOD evo RT System with HexaPOD evo Module 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-2018-RN-00560-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-05-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00560-1
  • 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
    Upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification. this description is not relevant for an iguide workflow (6d). the problem occurs only when a user switches from a 6d to a 3d workflow without iguide.
  • 조치
    Elekta is advising customers the correct position will be reached when the command to move the HexaPOD to the predefined 3D position is repeated. Users must perform this additional step without a patient on the HexaPOD after each change from the 6D workflow to the 3D workflow. Please refer to the respective User Manual for details how to initiate the movement. The manufacturer is currently investigating solutions to rectify this issue. Once available, Elekta will contact users to coordinate the required actions.

Device

HexaPOD evo RT System with HexaPOD evo Module
  • 모델명 / 제조번호(시리얼번호)
    HexaPOD evo RT System with HexaPOD evo ModuleARTG Number:187340(Elekta Pty Ltd - Table, radiation therapy, x-ray, powered)
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd