RaySearch Laboratories recalls specific versions of RayStation software (4.5.1-4.7.6) 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 (4.5.1-4.7.6) because inconsistencies in density calculations could lead to inaccurate treatment plans. This affects medical facilities using these software versions for radiation therapy treatments.
The software versions use density uncertainty calculations that could lead to incorrect radiation dose planning when converting CT scans to mass density. This risk is specific to proton and light ion treatments where precise density measurements are critical.
Medical facilities that use RayStation software versions 4.5.1-4.7.6 for radiation therapy planning are affected. Patients receiving treatment with these versions may be at risk of inaccurate radiation dosing.
Check if your RayStation software version is 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5, or 4.7.6. The software was sold between 2024 and 2025 with expiration date March 17, 2025.
Identify your RayStation version by checking the software menu or documentation.
Reach out to RaySearch Laboratories for guidance on whether your version is affected and next steps.
The recall addresses potential inaccuracies in radiation dose planning, but RaySearch Laboratories states this is a low-risk issue that requires verification by medical professionals.
Check if your RayStation version is 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5, or 4.7.6. The software was sold between 2024 and 2025 with expiration date March 17, 2025.
No immediate action is required. Affected facilities should contact RaySearch Laboratories to determine if updates or corrections are needed.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1195-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1195-2025 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.
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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.
