| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01021-1 |
| Product Name/Description |
Brianlab iPlan RT Image (versions below v.4.1.2) / iPlan RT and BrainSCAN (discontinued in 2002)
(Radiation therapy treatment planning system)
ARTG Number: 121114 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
The only image sets that are supported by the Brainlab Radiation Treatment Planning Software even when containing varying calibrations of pixel values in between image slices are CT image sets & PET image sets normalised to SUV with SUV also loaded in and displayed by the Brainlab SW
If such an unsupported image set is used the same pixel value calibration as contained in the middle image slice of the set to all slices is applied. In a PET image set uniform calibrated pixels might then have a different activity value, thus displayed with a different brightness and colour, compared to the image slices as displayed by the scanner using varying calibrations. If this effect occurs when using an unsupported image set, it can be misleading to the user during treatment planning and result in an incorrect definition of vols of interest in the planning s/w. The objects created for these vols of interest might differ in location or dimension from the actual desired definition of the structure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Brainlab will provide a software solution with the corresponding new feature for affected iPlan RT / iPlan RT Image customers to prevent the described scenario from occurring. In the interim, customers are advised to:
- Except for CT and PET used with SUV, only load and use image sets in iPlan RT / iPlan RT Imagethat have the same pixel value calibration for all images of the set.
- Before using image datasets loaded into the Brainlab Radiation Treatment Planning Software, always compare the images displayed in the Brainlab application to the images as displayed by the imaging device (scanner). Delete and do not use the image sets within iPlan RT in case any deviation is detected and contact Brainlab support.
Brainlab will not provide a software update for BrainSCAN. Brainlab strongly recommends customers still using BrainSCAN clinically to phase out the use of this software as soon as possible but in no event later than January 2016.
This action has been closed-out on 02/12/2016. |
| Contact Information |
(02) 9424 3800 - Brainlab Australia |