| 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 |
|
| 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 |