Important Safety Alerts

Medical device manufacturer, Brainlab AG, has issued a medical device safety alert concerning its ExacTrac v. 6.0.x Patient Positioning System due to display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification [Software version: ExacTrac v.6.0.0 through 6.0.5].

According to the manufacturer, an anomaly was detected in ExacTrac v.6.x when using ExacTrac version 6.0.0 through 6.0.5 for x-ray correction or verification of the patient position based on bony fusion. The phenomenon occurs under specific circumstances when using the ExacTrac x-ray module after a graphics memory error occurred at a previous patient positioning and the ExacTrac software has not been restarted since.

The manufacturer advises users to take the following actions:

• As generally required, always verify that the correct DRRs for the current patient are displayed in ExacTrac and an accurate fusion to the x-ray images is possible for patient positioning. In case incorrect DRRs would be displayed, exit and re-start the ExacTrac software.
• To minimize 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

The manufacturer will provide a software update to affected customers.

According to the local supplier, the affected product is distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 13 August 2015