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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00397-1
Product Name/Description Brainlab Cranial Navigation System, all versions
ARTG Number: 96517
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 3/05/2013
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
Recall Action Recall for Product Correction
Recall Action Instructions Brainlab are providing additional instructions for use regarding the correct use of the Brainlab Cranial Navigation System. End users are advised to continue to follow the instructions in the user manual and adhere to the measures documented in the additional instructions for use (Measures to Improve Cranial Navigation Accuracy).
Contact Information 02 9424 3800 - Brainlab Australia