RaySearch RayStation radiation therapy software recalled for dose calculation error
What this means
RaySearch RayStation/RayPlan radiation therapy planning software (versions 11B through 11B SPT1) has a bug that prevents dose calculations from updating correctly when changes are made to certain regions of interest with material overrides or specific geometry types. This could result in treatment plans using outdated radiation dose calculations.
- If your facility uses affected RayStation software versions, contact RaySearch Laboratories immediately
- Do not rely on dose calculations for regions of interest without contours until you receive a software update
- Verify your software version and check the distribution list to confirm if your facility 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-1104-2026More Raysearch Laboratories recalls
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