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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00558-1
Product Name/Description Brainlab Cranial Navigation System (all versions before Cranial 3.0)

Product Number: Brainlab Cranial Navigation System (all versions before Cranial 3.0)

ARTG Number: 96517
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 23/06/2015
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue Brainlab has detected that, when using the Brainlab Cranial Navigation System, the following may have a significant effect on the overall navigation accuracy:

• Large distance between reference array and region of interest
• Major changes of the camera position relative to the reference array during the procedure

Those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure. In the worst case scenario, these inaccuracies may cause an inaccurate display of instruments by the navigation system, compared to the actual patient anatomy. If these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
Recall Action Recall for Product Correction
Recall Action Instructions Brainlab has developed a software update to improve navigation accuracy. Brainlab will contact their customers to arrange for the installation of the update. This action is a follow-up to RC-2013-RN-00397-1.
This action has been closed-out on 05/12/2016.
Contact Information 02 9424 3800 - Brainlab