Important Safety Alerts

Medical device manufacturer, Brainlab, has issued a field safety notice advising users of a potential undesirable effect that might occur with the Pencil Beam Dose Algorithm of BrainSCAN version 5.31 or version 5.32 under specific conditions.

The BrainSCAN Pencil Beam Dose Algorithm may overestimate the dose delivered to the target region if both of the following conditions are met:

• The scatter measurements have been performed according to the Technical Reference Guide (TRG) "Brainlab Physics" (any revision), i.e. the scatter table was measured and implemented without values for equal jaw and MLC field sizes. AND
• In the treatment plan, the margin between jaw position and MLC field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement.

As a consequence, a dose lower than planned and intended might be delivered to the patient, potentially resulting in ineffective treatment.

According to the local supplier, the affected device has been distributed in Hong Kong. If you are in possession of the affected products, please contact supplier for necessary actions.