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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00731-1
Product Name/Description EXACTRAC Version 6.0.0 through to 6.0.5
(Image Guided Radiation Therapy Patient Positioning System)

Versions: 6.0.0; 6.0.1; 6.0.2; 6.0.3; 6.0.4; 6.0.5

ARTG Number 121226
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/08/2015
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue Loading and processing of large treatment plans, e.g. with a large image scan range and with a high number of outlined contours, may lead to an error in the ExacTrac internal graphic memory. After such a memory error has occurred, this might, under specific conditions, cause ExacTrac to display the Digitally Reconstructed Radiograph (DRR) of the previously loaded patient data set instead of the correct DRR during the positioning workflow of any subsequently opened patient treatment plan until the ExacTrac application is restarted.

This issue affects X-ray correction and verification based on bony fusion to the DRR. The Xray images acquired for current patient positions are not affected and still correct even if this issue occurs. Only if the mismatch of displayed patient image data in ExacTrac is not discovered by the operator, the incorrect DRR might be used for image fusion to the acquired x-ray images, potentially resulting in the calculation of an incorrect shift.
Recall Action Recall for Product Correction
Recall Action Instructions Brainlab will provide a software revision (ExacTrac v. 6.0.6) with this issue solved to
affected customers.Brainlab will contact affected customers starting December 2015 to schedule the update. In the interim, to minimise the probability of this issue to occur for the affected ExacTrac versions:
- Reduce the amount of contours exported to ExacTrac as far as possible (export only
contours needed for positioning to ExacTrac).
- Avoid exporting large contours, such as couch top models, to ExacTrac.
- After every (re-)start of the ExacTrac application on any workstation, always first load
a phantom plan not containing contours. Generate DRRs of that phantom plan once
by selecting the Define DRR Settings tab, before loading any other patient treatment
plans. This action has been closed-out on 17/08/2016.
Contact Information 02 9424 3800 - Brainlab Australia