Events

Recall of BrainLab Navigation Software Spine and Trauma 3D 2.0 (intra-operative image guided stereotactic localisation system to enable precision spine and trauma surgeries)

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-01266-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01266-1
  • 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
    In the ‘fluoro match registration’ function when used in combination with a digitally integrated c-arm, the software algorithm may not find an adequate match between the intraoperatively acquired 2d fluoroscopic images and the preoperative ct or other compatible 3d datasets. due to a software anomaly the intraoperative 2d fluoroscopic images are not correctly processed, causing a low contrast of the images potentially resulting in the software algorithm being unable to find a correct match between the low contrast 2d fluoroscopic images and the segmented area of the 3d dataset. alternatively, it may incorrectly match the segmented area to the spine reference x-clamp. for an incorrect match, the display of instruments by the navigation system would be shifted compared to the actual patient anatomy. if this is not detected during user verification, deviation of position information could impact clinical decisions which could lead to ineffective treatment, serious injury or patient death.
  • Action
    Brainlab will provide a software update to affected customers with this issue resolved. As a temporary solution, until the software update has been implemented, users of the Navigation Software Spine & Trauma 3D 2.0 are advised to adhere to the workaround instructions in the customer letter. This action has been closed-out on 01/02/2016.

Device

BrainLab Navigation Software Spine and Trauma 3D 2.0 (intra-operative image guided stereotactic l...
  • Model / Serial
    BrainLab Navigation Software Spine and Trauma 3D 2.0 (intra-operative image guided stereotactic localisation system to enable precision spine and trauma surgeries)ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd