Events

Rappel de Brainlab Patient Data Manager

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00784-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00784-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Brainlab Patient Data ManagerProduct Version Number: 2.0Sub Versions: 2.0.0, 2.0.1 & 2.0.2ARTG Number: 96517
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd