Events

Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with 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-2013-RN-00532-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-06-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00532-1
  • 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
    After the mandatory upgrade of xvi systems from xvi r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3), elekta has found that some customers are still operating on the incorrect software build of the xvi r4.5.1 b138 software. the correct build is r4.5.1 b141. the software update from r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3) was to permanently correct a software problem that prevents the operation of the database reindex function and also, prevents the error that incorrectly causes a kv gating inhibit during segmental volumeview.
  • 조치
    If XVI Release 4.5.1 b141 is displayed on the logon screen, no further action is required. If XVI Release 4.5.1 b138 is displayed end users must contact their service representative immediately. Instructions to complete the upgrade to the correct software build are also being provided to end users.

Device

Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation thera...
  • 모델명 / 제조번호(시리얼번호)
    Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)Software version 4.5.1 b138ARTG number: 165040
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd