| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01293-1 |
| Product Name/Description |
iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1)
ARTG Number: 121114 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Incorrect patient positioning at the linac might occur, if all of the following conditions are met:
1. At least two different CT datasets are being used and have been both localized and fused to
each other in the same treatment plan.
2. The latest CT scan used with the localizer is not assigned as both Reference Set and Alignment
Set (for definitions, see the appendix).
3. Patients are positioned at the linac using one of the following positioning solutions:
- Target Positioner
- ExacTrac v.4.5 or v.5.x
- ExacTrac Vero (from v.2.1 up to v.3.2.1)
The magnitude of potentially incorrect patient positioning is given by the difference in patient position inside the localizer during the two CT scans, one of which was assigned to the Reference Set and the other to the Alignment Set. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1) Brainlab will provide existing potentially affected iPlan RT / iPlan RT Dose customers with this product notification information.
2) 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.
3) Brainlab will refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update. This action has been closed-out on 22/08/2016. |
| Contact Information |
02 9424 3800 - Brainlab |