RaySearch recalls RayStation software versions 15.2.0 and 15.1.3 due to potential radiation dose calculation errors for certain treatment areas. Affected users should contact RaySearch for updates.
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.
RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software. The software may incorrectly calculate radiation doses for certain treatment areas, which could lead to unsafe radiation exposure during cancer treatment.
The software may fail to properly invalidate radiation dose calculations for certain treatment areas when those areas have no contours or specific material overrides. This could result in incorrect radiation doses being delivered during cancer treatment.
Radiation therapy professionals using RayStation software versions 15.2.0 and 15.1.3 for cancer treatment planning. Those with specific ROI configurations may face inaccurate dose calculations.
Check if your software version is 15.2.0 or 15.1.3. The product was sold with RayStation 2024A SP1 or SP2 software versions. The serial numbers 15.1.0.852 and 15.2.0.107 are associated with these versions.
Verify your RayStation software version is 15.2.0 or 15.1.3.
The software may incorrectly calculate radiation doses for certain treatment areas, which could lead to unsafe radiation exposure during cancer treatment.
Contact RaySearch Laboratories directly for guidance on next steps.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1108-2026 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1108-2026 from RaySearch. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
