Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00339-1 |
Product Name/Description |
iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system)
ARTG Number: 121114 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
19/04/2013 |
Responsible Entity |
|
Reason/Issue |
iPlan RT Dose version 4.0 and 4.1 might not correctly refresh the dose calculation after certain MLC shape modifications if all of the following conditions are met: - The modifications are performed for a Dynamic Conformal Arc, and - The jaw positions are defined manually, and - The dose display (e.g. isodose lines) is turned on, or if the dose has already been calculated and the dose display is turned on again after the MLC shape was modified.
The effect may occur for the following modifications of the MLC shape: - The MLC margin of the arc is modified - The MLC shape is modified in the beam’s eye view (BEV) in a way that also changes the MLC shapes of neighbouring segments of the arc1 - The Leaf Adaption is modified (Inline/Average/Outline) - The modified MLC shapes in the BEV are reset
The dose calculation is not refreshed in the Physician’s Review and Physicist’s Verification tasks or when generating the printout or exporting the plan. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Brainlab is providing work around instructions and is developing a software update to permanently correct the problem. |
Contact Information |
02 9424 3800 - Brainlab Australia |