Events

Recall of ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5

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-2018-RN-00137-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00137-1
  • 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
    When using exactrac on a varian clinac or varian truebeam system equipped with the adi, beam requests of the treatment application have to be authorized by exactrac to enable treatment. as per the ifu, if no patient data is loaded in exactrac, exactrac always authorizes every beam request from the varian side. this is required and intended for clinical treatments where exactrac is not used for patient positioning. brainlab is clarifiying that the beam authorization by exactrac via adi is not a safety feature to ensure correct patient positioning before treatment.For any treatments performed with exactrac always verify that exactrac confirms the target position by displaying the ok icon. if a deviation of the patient position from the planned treatment position remains undetected by the user and the actual treatment beam that has been previously authorized by exactrac via adi is initialized, underdose of the planned target and/or overdose of healthy tissue could occur.
  • Action
    Brainlab is advising users to always follow the IFU during use and to verify that ExacTrac confirms the target position by displaying the OK icon. Brainlab is providing updated Instructions for use. For treatments that have already been performed, the actual patient position during treatment can be reviewed in the treatment report of ExacTrac, and by using the Review function in the ExacTrac software.

Device

ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5
  • Model / Serial
    ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5ARTG Number: 121226 (Brainlab Australia Pty Ltd - ExacTrac / Novalis Body - Patient positioning device, diagnostic imaging/radiotherapy, whole body)
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd