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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00218-1
Product Name/Description ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)

ARTG: 121226
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 8/03/2013
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue After performing a Snap Verification, that is a monoscopic Intra-Fraction X-ray Monitoring using only one X-Ray tube, in combination with implanted markers, the ExacTrac 6.0 X-ray Monitoring tab might display an incorrect hint icon and result text. ExacTrac might incorrectly show the hint icon in green colour with the result text “No Deviation detected”, despite the simultaneously displayed unaffected X-ray image showing the actual positions of the implanted markers potentially deviating from the user defined tolerance areas .
Recall Action Recall for Product Correction
Recall Action Instructions Brainlab is asking customers to always verify the result of a Snap verification within the simultaneously displayed x-ray images generally required and never exclusively rely on the hint icon colour and the result text only. Brainlab will provide a software update to affected customers around end of August 2013 to correct the issue.
Contact Information 02 9424 3800 - Brainlab Australia Pty Ltd