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Elekta Integrity Digital Linear Accelerator, version 1.1 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-00334-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00334-1
  • 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 "static tolerances" in the calibration files (loaded database) for the unwanted movement during the beam delivery are incorrect, the unwanted movement may not terminate treatment. this is only a problem if a malfunction such as a brake failure or an equivalent fault occurs during beam delivery.
  • 조치
    Elekta is advising that the solution to the problem is to apply the Integrity 1.1 Static Tolerance Updater Tool. This tool will need to be re-applied, if a new Linac license is applied in the future. A complete solution will be included in the next release of the software.

Device

Elekta Integrity Digital Linear Accelerator, version 1.1
  • 모델명 / 제조번호(시리얼번호)
    Elekta Integrity Digital Linear Accelerator, version 1.1ARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd