Events

Recall of Brainlab Patient Data Manager

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00784-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00784-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

Manufacturer

Brainlab Australia Pty Ltd