iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software) 의 리콜

Recall

RC-2015-RN-00616-1

Class I

2015-07-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00616-1

The automatic monitor units (mu) calculation (normalisation) might be incorrect in the brainlab iplan rt dose versions 4.0 and 4.1 if all of the following conditions are met: - several ptvs are planned in the treatment plan, and - at least one treatment group or treatment element is locked to prevent further modification, and - for any ptv with a locked treatment group or with at least one locked treatment element assigned the dose at the 50% volume constraint point deviates more than 5% from the actual dose at 50% volume.If the mu calculation is refreshed, the software will always normalise the dose of the ptvs, which do not have a locked treatment group or treatment element assigned, to the 50% volume constraint point. other constraint points for the ptvs will be disregarded even if a constraint point is set “hard constraint” and therefore the intended prescription will not be automatically fulfilled for ptvs without a locked treatment group or locked treatment element.

Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update. This action has been closed-out on 12/08/2016.