RayStation 2024B radiation therapy software recalled for dose calculation error
What this means
RayStation version 2024B has a software issue where calculated radiation doses may not update 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. Clinics using this version should verify their dose calculations are accurate.
- Contact RaySearch Laboratories for a software update or patch
- Review recent treatment plans using version 2024B to ensure dose calculations are correct
- Do not proceed with treatment if dose recalculation appears incorrect
- Check your facility's distribution list to confirm if your system is affected
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-1109-2026More 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.