Events

Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator) 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-01290-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01290-1
  • 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
    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values. if the user does not do the quality assurance (qa) procedures after the calibration, it is possible that the user will not find the error made during the calibrationif the treatment table, gantry or collimator calibration is incorrect, and the user does not perform the recommended qa procedures, it can cause clinical mistreatment, with errors up to 6cm could go undetected and repeated over a number of fractions.
  • 조치
    As an interim measure, Elekta is recommending users perform the daily QA procedures as per the Instructions for Use (IFU) and perform a daily check to ensure the magnitude and direction of the treatment table movements are correct. If a user has X-ray Volume Imager (XVI), Elekta is recommending users perform the QA procedures as per the XVI IFU and perform the daily phantom scan. All users of Integrity 3.1 software will be informed of a mandatory upgrade to software version 3.2 upon its release in February 2014. This action has been closed-out on 18/02/2016.

Device

Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)
  • 모델명 / 제조번호(시리얼번호)
    Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)ARTG Number: 191025
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd