RayStation radiation therapy planning software recalled for dose calculation error
What this means
RayStation versions 17.0.0 and 17.0.1 have a software error that prevents dose calculations from updating properly when certain regions of interest are modified. This can occur when regions have no contours but include material overrides or are marked as Bolus, Fixation, or Support types. Users may not see updated radiation doses after making changes.
- Contact RaySearch Laboratories for a software update or patch
- Verify your RayStation version matches the affected versions (17.0.0, 17.0.1, RayStation v2025, or RayStation v2025 SP1)
- Review recent treatment plans using the affected software 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-1110-2026More Raysearch Laboratories recalls
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