RayStation radiation therapy planning software recalled for dose calculation errors
What this means
RayStation versions 12A, 12A SP1, and 12A SP2 contain a software bug that prevents dose calculations from updating properly when certain regions are edited. This affects only specific region types (Bolus, Fixation, Support) with no contours that have material overrides. Users may not see updated radiation doses after making changes.
- Check if your RayStation installation is version 13.0.0.1547, 13.1.0.144, or 13.1.1.89
- Contact RaySearch Laboratories for a software update or patch
- Do not rely on dose calculations for affected regions until your system is updated
- Verify any treatment plans created with these versions for accuracy
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-1105-2026More Raysearch Laboratories recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.