RayStation v2025 and v2025 SP1 software versions 17.0.0 and 17.0.1 may cause radiation dose calculations to fail for certain treatment areas. Affected users should contact RaySearch Laboratories 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, potentially leading to unsafe radiation exposure during cancer treatment.
The software may fail to correctly calculate radiation doses for certain treatment areas when specific conditions are met, such as when the treatment area has no contours or specific material overrides. This could lead to incorrect radiation delivery during cancer treatment.
Radiation therapy professionals using RayStation software versions 17.0.0 and 17.0.1 are affected. Patients receiving treatment with these versions may be at risk of inaccurate radiation dosing.
Check if your RayStation software version is 17.0.0 or 17.0.1. The software is sold as RayStation v2025 or v2025 SP1 with expiration date 2030-10-22.
Review your RayStation software version to confirm if it is 17.0.0 or 17.0.1.
The recall indicates a potential issue with radiation dose calculations, but the risk level is low as the software may not invalidate doses for certain treatment areas. The manufacturer has not specified immediate safety risks.
Contact RaySearch Laboratories directly for guidance on next steps. The recall does not include a specific remedy or action for users.
Check your RayStation software version; affected versions are 17.0.0 and 17.0.1, sold as RayStation v2025 or v2025 SP1 with expiration date 2030-10-22.
We’ve drafted a message you can send RayStation to request your refund or repair — edit it as you like.
Subject: Recall Z-1110-2026 — RayStation RayStation Hello, I own a RayStation that is covered by recall Z-1110-2026 from RayStation. 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.
