RaySearch recalls RayStation 14.0.0, 15.0.0, and 15.1.3 software versions 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 is recalling specific versions of its RayStation radiation therapy software because it may not correctly calculate radiation doses for some treatment areas. This could lead to incorrect radiation delivery during cancer treatment, potentially affecting patient safety.
The software may fail to properly invalidate radiation dose calculations for certain treatment areas (ROIs) that have no contours or specific material overrides. This could result in incorrect radiation delivery during cancer treatment procedures.
Healthcare professionals using RayStation software for radiation therapy planning. Patients receiving treatment with affected software versions are at risk of incorrect radiation dosing.
Check if your RayStation software version is 14.0.0, 15.0.0, or 15.1.3. The software is sold with specific versions: RayStation 2023B, RayStation 2024A, and RayStation 2024A SP3.
Verify your RayStation software version by checking the version number in the software interface.
RayStation 14.0.0, 15.0.0, and 15.1.3 software versions (RayStation 2023B, 2024A, and 2024A SP3).
The software may not correctly calculate radiation doses for certain treatment areas, potentially leading to incorrect radiation delivery during cancer treatment.
Contact RaySearch directly for guidance on updating to a safe version or other remedies.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1106-2026 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1106-2026 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.
