| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00489-1 |
| Product Name/Description |
RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system)
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, RaySearch Laboratories has identified a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution. The problem has, to the best of RaySearch Laboratories' knowledge, not caused any patient mistreatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This problem will be resolved in a future release of RayStation. Customers wanting to continue to use variable slice spacing should contact their Support representative for workarounds. RayStation 4.0.3 may not be used with CT data where variable slice spacing has been used, until a workaround has been provided. For now, applicable CT scanners should, if possible, be configured to uniform slice spacing. If there are patient plans with variable CT slice spacing being used for treatment, please contact Support representative for assistance on identifying if the problem is present and workarounds. The database of patients planned with RayStation 4.0.3 should be analysed for identification of potential errors in dose analysis for completed treatments. This action has been closed-out on 01/02/2016. |
| Contact Information |
02 9006 1662 - Emergo Australia |