iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC) 의 리콜

Recall

RC-2016-RN-01317-1

Class I

2016-10-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01317-1

The agility mlc controller automatically adds a physical gap of 1mm (about 3mm projected to the isocenter) between opposing closed leaf pairs. therefore, leakage radiation through this gap must be correctly considered during treatment planning and dose calculation. due to a software inconsistency, the brainlab pencil beam dose calculation algorithm does not correctly regard and represent this gap if all of the following conditions are met:1. iplan rt dose v. 4.5.3 or 4.5.4 is used.2. the planning option for agility mlc is used for a treatment plan.3. the machine profile (dose profile entered in the brainlab treatment planning software) for the used agility mlc and linear accelerator combination contains a leaf shift static value different than 0mm.If the above described conditions are met, only specific plans irradiating multiple separate target volumes simultaneously with a single isocenter are affected.

Users are advised to immediately check the Leaf Shift Static value in all the machine profiles in iPlan RT Dose for an Agility MLC: Ensure that this value is set to “0 mm”. If another value is found, please change this specific value to 0 in order to permanently resolve the described potential issue. The users are also reminded of the following information which is in the current IFU: - For any new or changed machine profiles, it is highly recommended to perform a dose verification (using a phantom) before clinical use, to ensure adequate implementation and accuracy of dose calculation. - Patient-specific Quality Assurance of a treatment plan and verifying the dose distribution (in a suitable phantom) is highly recommended before irradiating the patient. Brainlab will be offering a software solution and will contact affected customers starting November 2017 to implement the update free of charge.