RaySearch recalls specific versions of RayStation software (12A, 12A Service Packs 1-2, 2023B) due to density uncertainty issues in radiation therapy planning that could affect treatment 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 specific versions of their RayStation radiation therapy software because of inconsistencies in density calculations. This could lead to inaccurate treatment planning for proton and light ion therapy, potentially affecting patient safety.
The software has a density uncertainty issue when converting CT scans to mass density for proton and light ion treatments. This inconsistency could cause errors in radiation dose calculations, potentially affecting treatment accuracy.
Healthcare providers using RayStation software versions 12A, 12A Service Packs 1-2, and 2023B are affected. Medical professionals who plan radiation treatments with these versions face the highest risk.
Check for software version numbers 12A, 12A Service Pack 1 or 2, and 2023B. Also look for lot codes starting with 07350002010549, 07350002010679, 07350002010730, or 07350002010556.
Review the software version number to see if it matches 12A, 12A Service Pack 1, 2, or 2023B.
Check the lot code on the software packaging or documentation for codes starting with 07350002010549, 07350002010679, 07350002010730, or 07350002010556.
RayStation versions 12A, 12A Service Pack 1 and 2, and 2023B are affected.
Check the software version number and lot code. Affected versions include 12A, 12A Service Packs 1-2, 2023B, and lot codes starting with 07350002010549, 07350002010679, 07350002010730, or 07350002010556.
No action is needed if your software version and lot code do not match the recalled versions.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1191-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1191-2025 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.
