Events

Recall of Brainlab Navigation System Spine & Trauma 3D

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-2017-RN-01486-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01486-1
  • 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 determined that due to a human error at a brainlab supplier, an unknown number of items within one specific production lot of brainlab drapelink adapters (left/right) were not manufactured according to defined specifications.Due to this manufacturing error the required reproducible rigid fixation between drapelink c-arm array and adapter cannot be ensured in all cases.
  • Action
    Brainlab is advising users to isolate units with the specified serial numbers from use. A Brainlab Customer Support Representative will contact customers to arrange a service visit to collect and replace the potentially affected item.

Device

Brainlab Navigation System Spine & Trauma 3D

Manufacturer

Brainlab Australia Pty Ltd