Important Safety Alerts

Medical device manufacturer, Brainlab AG, has issued a medical device safety alert concerning its ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software [Software version: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0), in combination with Varian C-Series linac only].

According to the manufacturer, an anomaly was detected in ExacTrac v.6.x during phantom based acceptance testing. The phenomenon occurs under specific circumstances when using the ExacTrac CBCT module with Varian CBCT images acquired with a Varian C-Series linear accelerator (linac) at a couch angle other than 0.0°.

The manufacturer advises users to take the following actions:

• With immediate effect, always make sure the couch is at exactly 0.0° (displayed on the Varian monitor) when acquiring a CBCT set to import into the ExacTrac software.
• For Varian systems providing an option to prevent a CBCT acquisition for couch angles other than 0.0°, the manufacturer recommends selecting that option for use in combination with ExacTrac.
• Continue to verify any ExacTrac CBCT based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory.

The manufacturer will provide a software update to affected customers.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 23 April 2015