Events

Recall of Standard Cranial Reference Array (used with Vector Vision Cranial Navigation 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-2012-RN-00962-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00962-1
  • 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
    Manufacturing tolerance's of the standard cranial reference array influence the actual position of its marker spheres. the differences between the individual arrays are very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery.This recall action was not notified to the tga before it was initiated by brainlab australia.
  • Action
    The sponsor is advising users to follow work around instructions and will provide a hardware update to correct the issue.

Device

Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)
  • Model / Serial
    Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)Product Codes: 41735 & 41730A
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd