Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00904-1 |
Product Name/Description |
RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5 (Radiation therapy treatment planning system)
ARTG Number: 195288 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
12/07/2016 |
Responsible Entity |
|
Reason/Issue |
There is an issue with the evaluation of biological clinical goals in RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5. This issue occurs when adaptive replanning (rayAdaptive) is used in combination with biological models (rayBiology) and can only occur for a user licensed for rayAdaptive and rayBiology concurrently. Biological clinical goals for an adapted plan based on a new CT (not the planning CT used for the original plan) are evaluated using incorrect dose values and will therefore display incorrect values. The issue is present in all views displaying biological clinical goals, for adapted plans based on a new CT. The magnitude of the error is irregular and largely dependent on the differences between the original planning CT and the new CT. The computed TCP/NTCP values may be smaller or larger than the correct values. The issue has not caused any patient mistreatment or other incidents. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
The issue will be resolved in the next version of RayStation, scheduled for market release in December 2016. In the interim, users are advised:
- Do not use the values displayed for biological clinical goals in clinical decision making when performing adaptive replanning. - The user is referred to using corresponding biological objective functions or biological functions defined in the Biological Evaluation module. These are evaluated correctly. - As stated in the RayStation Instructions for Use, always evaluate the physical dose.
This action has been closed out on the 12/10/2018. |
Contact Information |
02 9006 1662 - Emergo Australia |