Events

Recall of Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1

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-2015-RN-00396-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00396-1
  • 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 navigation software offers automatic registration of ct image data sets, intraoperatively acquired with an integrated neurologica bodytom portable ct scanner (“bodytom”). in the course of clinical usage of these devices at different hospitals, registration inaccuracies have been identified in some instances when using automatic registration with bodytom. in these cases the data set could not be accurately registered to the actual patient anatomy when performing automatic registration. an accurate registration (match between ct image data set virtually displayed in navigation and the current patient anatomy) is essential for a successful navigation.If a potentially inappropriate registration is not detected during user verification, the deviation of the position information in the navigation software could mislead the user regarding clinical decisions. this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
  • Action
    To reduce the risk of an inappropriate automatic registration, Brainlab in cooperation with NeuroLogica has developed an improved integration and verification workflow to be followed by users which is provided with the customer letter. Brainlab will individually contact each affected customer to offer: a) a service visit to assist in the selection and marking of a suitable movement path and to perform the calibration and verification in cooperation with Neurologica. b) an additional training regarding the improved verification methods. This action has been closed-out on 08/08/2016.

Device

Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial ...
  • Model / Serial
    Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1 ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd