Events

Recall of ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)

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-2013-RN-00218-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00218-1
  • 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
    After performing a snap verification, that is a monoscopic intra-fraction x-ray monitoring using only one x-ray tube, in combination with implanted markers, the exactrac 6.0 x-ray monitoring tab might display an incorrect hint icon and result text. exactrac might incorrectly show the hint icon in green colour with the result text “no deviation detected”, despite the simultaneously displayed unaffected x-ray image showing the actual positions of the implanted markers potentially deviating from the user defined tolerance areas .
  • Action
    Brainlab is asking customers to always verify the result of a Snap verification within the simultaneously displayed x-ray images generally required and never exclusively rely on the hint icon colour and the result text only. Brainlab will provide a software update to affected customers around end of August 2013 to correct the issue.

Device

ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)
  • Model / Serial
    ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)ARTG: 121226
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd