| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00204-1 |
| Product Name/Description |
EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)
Product Version Number: ExacTrac 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0
ARTG Number: 121226 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Brainlab has internally detected an unexpected phenomenon for ExacTrac v.6.x that could occur when using the ExacTrac Cone Beam CT (CBCT) module in combination with actively re-reconstructed CBCT images of a subvolume from the original CBCT volume.
If a user-defined actively re-reconstructed CBCT subvolume is imported into ExacTrac, ExacTrac cannot regard the position of this CBCT subvolume correctly. If the center of this subvolume differs from the center of the original CBCT volume, this leads to an erroneous calculation of patient shifts needed to move the patient to the planned treatment position. If the corresponding calculated shifts and rotations are applied with ExacTrac, the patient will be positioned incorrectly at the linac. If not detected by the user, the radiation treatment dose at the linac may be delivered to an unintended target position. If the deviation exceeds clinically acceptable limits, this could result in mistreatment, serious patient injury, or even death. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Affected customers will be contacted starting August 2015 to schedule the installation of the software update In the interim, customers are advised to not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module with immediate effect. Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning. Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. This action has been closed-out on 1/06/2016. |
| Contact Information |
02 9424 3800 - Brainlab Australia Pty Ltd |