RaySearch Laboratories recalls RayStation software versions 11A and 11A Service Packs 1-3 with model numbers 1.0.0.951 and others due to density uncertainty errors in radiation therapy planning.
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 that could affect treatment accuracy. This recall affects medical professionals using the software for radiation therapy planning.
The software has inconsistencies in density uncertainty calculations when using certain CT calibration curves. This could lead to incorrect radiation dose calculations for proton and light ion treatments, potentially affecting treatment accuracy.
Medical professionals who use RayStation software for radiation therapy treatment planning are likely affected. Patients receiving treatment with these versions may be at risk of inaccurate radiation dosing.
Check for model numbers 1.0.0.951, 11.0.1.29, 11.0.3.116, or 11.0.4.15. The software versions include RayStation 11A and service packs 1-3 with specific lot codes and expiration dates.
Verify your RayStation version by checking the software revision and model numbers listed in the recall notice.
The recall describes a potential inconsistency in density calculations that could affect treatment accuracy, but the official notice does not specify if this poses a risk of serious injury or death.
Versions 11A and service packs 1-3 with model numbers 1.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15.
Check your software version and model numbers against the list provided in the recall notice, including lot codes and expiration dates.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1189-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1189-2025 from RaySearch Laboratories. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
