Events

iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment) 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-2016-RN-01116-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01116-1
  • 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
    Iguide monitors if the hexapod is in the pre-defined 3d position. if it is not in this position an inhibit is set. for 3d treatments there is no iguide interlock check possible. in the event of a malfunction of the interlock system an inhibit in iguide may not lead to an external inhibit on the linac. there is the potential for unrecognised incorrect position of the treatment couch in 3d workflow, i.E. the hexapod has not moved fully to the 3d position.
  • 조치
    Elekta is advising user that if users do not intend to use iGUIDE for patient positioning, make sure the HexaPOD is at its pre-defined 3D position before treatment. The 3D position is confirmed in the iGUIDE login screen (no inhibit icon) or in the iGUIDE System Overview. In addition the External Inhibit LED at the Enable Switch Board must be off. It is recommended to perform the Interlock Check in the iGUIDE software on a daily basis. This information has been included in the Instructions For Use (IFU). This action has been closed-out on 09/05/2017.

Device

iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient pos...
  • 모델명 / 제조번호(시리얼번호)
    iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment) ARTG Number: 187340
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd