RaySearch recalls RayStation software versions 5.0.2.35 and 5.0.3.17 due to density uncertainty issues affecting radiation therapy treatment plans. Affected units may require correction to prevent errors in proton and light ion treatments.
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 recalls specific versions of its RayStation radiation therapy software due to inconsistencies in density calculations. This could lead to errors in treatment planning for proton and light ion therapies if the software uses an outdated calibration curve.
The software may use an outdated CT calibration curve (from version 4.5 to 2024B) that causes density uncertainty errors. This affects robust optimization, dose calculations, and treatment plan accuracy for proton and light ion therapies.
Medical professionals using RayStation software versions 5.0.2.35 and 5.0.3.17 for radiation therapy planning. Patients receiving proton or light ion treatments may be at risk if the software is misconfigured.
Check for software versions 5.0.2.35 and 5.0.3.17, service packs 2 and 3, or lot codes starting with UDI: 0735000201002020170502. The software was sold between 2017 and 2028.
Verify your RayStation version by checking the software menu or documentation.
Apply service packs 2 or 3 if your version is 5.0.2.35 or 5.0.3.17 to correct density calculations.
The recall addresses potential errors in treatment planning for proton and light ion therapies, but it does not indicate immediate patient harm. Affected users should update the software to prevent errors.
Check for software versions 5.0.2.35, 5.0.3.17, service packs 2 or 3, or lot code UDI: 0735000201002020170502. The software was sold between 2017 and 2028.
No. The recall requires updating the software to correct density calculations, but users can continue using it safely after applying the service packs.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1194-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1194-2025 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.
