| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01641-1 |
| Product Name/Description |
iPlan RT, iPlan RT Dose and BrainSCAN
All Software versions
ARTG Number: 121114 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Brainlab has identified an issue where there is the possibility of a potential inaccurate dose calculation for small MLC-shaped fields when using the Pencil Beam algorithm.
The Pencil Beam algorithm refers to beam data which is acquired by performing dose measurements for MLC fields at predefined field sizes and which are stored using the iPlan RT Physics Administration / BrainSCAN Beam Profile Editor.
Due to an inaccurate implementation in the Brainlab radiation treatment planning software, the interpolation between two measured values is less accurate
a) the smaller the field and;
b) the further away the equivalent field size is from the measured value.
For certain treatment setups, this leads to the effect that an insufficient amount of Monitor Units (MU) is calculated and that consequently the delivered dose is lower than the planned dose. For clarity, the delivered dose does not exceed the planned dose due to the described issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As a workaround, to reduce the described dose deviation to less than 2% using the Pencil Beam algorithm in iPlan RT 4.5.x Brainlab recommends to modify the machine profile following the instructions outlined in the Appendix provided.
For all Brainlab treatment planning systems, as recommended by Brainlab, perform proper pre-treatment quality assurance for every treatment plan. Independent calculation of the dose using 3rd party QA Software or dose measurements inside a phantom is suitable to judge the accuracy of the dose calculation. Refer to the Brainlab Physics Technical Reference Guide for details.
This action has been closed out on the 12/11/2018. |
| Contact Information |
02 9424 3800 - Brainlab Australia |