RayStation radiation therapy software recalled for dose calculation error
What this means
RayStation radiation therapy planning software versions 2024A SP1 and 2024A SP2 have a bug that prevents dose calculations from updating correctly when certain regions of interest (ROIs) are modified. This affects ROIs without contours that have material overrides or are classified as Bolus, Fixation, or Support types. If changes are made to these ROIs, the system may not recalculate doses as intended.
- Verify your RayStation software version (15.1.3 or 15.2.0)
- Contact RaySearch Laboratories for patched software or workaround instructions
- Review any treatment plans created or modified with affected ROI types for accuracy
- Do not proceed with treatments until dose calculations are verified correct
The agency's original wording
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2026More Raysearch Laboratories recalls
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