RaySearch recalls RayStation software versions 11B and service packs due to density uncertainty errors in radiation treatment planning, potentially affecting proton and light ion therapy accuracy.
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
RaySearch Laboratories is recalling RayStation software versions 11B and service packs that may have density uncertainty errors in radiation therapy planning. This could lead to inaccurate treatment for proton and light ion therapies if the software is used without correction.
The software may use inconsistent density uncertainty calculations when performing robust optimization, robust evaluation, or compute perturbed dose for proton and light ion treatments. This occurs when a HU-to-mass density CT calibration curve from RayStation versions 4.5 to 2024B is used.
Radiation therapy professionals using RayStation software versions 11B and service packs for proton or light ion treatment planning are most at risk. Patients receiving these treatments may be affected if the software is not corrected.
Check for software versions 11B and service packs 1-3, or service pack Toshiba 1. Look for serial numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, and 12.3.0.119. The software was sold between 2021 and 2022.
Verify your RayStation version by checking the software menu or documentation for versions 11B and service packs 1-3.
Reach out to RaySearch Laboratories for guidance on correcting the density uncertainty issue if you have the recalled software.
The recall indicates potential inaccuracies in radiation treatment planning for proton and light ion therapies, but the software is not inherently dangerous. Patients should follow their treatment team's instructions.
Check for software versions 11B and service packs 1-3, or service pack Toshiba 1. Serial numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, and 12.3.0.119 indicate the recalled versions.
The recall does not require immediate discontinuation. Users should contact RaySearch for correction steps if they have the recalled software.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1190-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1190-2025 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.
