Events

HexaPOD evo RT Couchtop (X-ray powered radiation therapy table) 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-2014-RN-00468-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00468-1
  • 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
    If the screws that secure the hexapod evo rt couchtop are not adequately tightened during installation, they may loosen over time. this condition has the following possible impacts: - there may be incorrect patient repositioning if the hexapod evo rt couchtop is moved.- the hexapod evo rt couchtop could tip when a patient is in a highly extended position (which could be the case in treatments of the lower body half).
  • 조치
    Elekta is advising their customers to check each screw to determine if it is loose. If any screw is loose the HexPOD evo RT system must be taken out of service and the service engineer responsible for the equipment should be contacted. The service engineer will tighten the screws to 20 Nm before the couchtop can be used.

Device

HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)
  • 모델명 / 제조번호(시리얼번호)
    HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)ARTG Number: 187340
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd