Events

Brainlab Patient Data Manager 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Brainlab Australia 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-00784-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-07-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00784-1
  • 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
    Brainlab has identified two potential problems when loading image data that consists of non-square pixels with pdm 2.0. 1- display of image data: when loading non-square pixel image data with pdm 2.0, the data set is not correctly transferred and displayed in the corresponding brainlab navigation or planning software. 2- dose calculation: it has been determined that non-square pixel data is not suitable for dose calculation with the current brainlab iplan rt systems.
  • 조치
    End users are advised to not load image data sets with non-square pixels if Brainlab Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2) is installed at your hospital. Brainlab will provide a software update to affected customers to correct this issue. This action has been closed-out on 01/03/2016.

Device

Brainlab Patient Data Manager
  • 모델명 / 제조번호(시리얼번호)
    Brainlab Patient Data ManagerProduct Version Number: 2.0Sub Versions: 2.0.0, 2.0.1 & 2.0.2ARTG Number: 96517
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd