RayStation radiation therapy planning software recalled for potential dose calculation errors
What this means
RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may not properly update calculated radiation doses when certain regions of interest are modified. This can occur when regions have no contours but have material overrides or are classified as bolus, fixation, or support types. Changes to these regions may not trigger the dose recalculation as intended.
- Contact RaySearch Laboratories if your facility uses affected RayStation software versions
- Review recent treatment plans created with versions 2023B, 2024A, or 2024A SP3
- Do not rely on automatic dose recalculation for regions of interest with no contours until your software is updated
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-1106-2026More Raysearch Laboratories recalls
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