RaySearch Laboratories recalls RayStation software versions 6.1.1.2, 6.2.0.7, and 6.3.0.6 due to density uncertainty errors 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 inconsistencies in density calculations could lead to inaccurate treatment plans. This affects medical professionals using the software for radiation therapy treatments.
The software uses density uncertainty calculations that can vary when converting CT scans to mass density, potentially causing errors in radiation therapy treatment planning. This risk is specific to certain versions of RayStation software and may affect the accuracy of treatment doses for patients.
Medical professionals using RayStation software versions 6.1.1.2, 6.2.0.7, and 6.3.0.6 for radiation therapy planning are most at risk. Patients receiving treatment with these versions may experience inaccurate radiation dosing.
Check for software versions 6.1.1.2, 6.2.0.7, or 6.3.0.6 with service packs 1, 2, or 3. The software may also have lot codes starting with 0735000201008220170529, 0735000201007520170630, or 0735000201024220190923.
Verify the software version by checking the RayStation interface or documentation for versions 6.1.1.2, 6.2.0.7, or 6.3.0.6.
Reach out to RaySearch Laboratories for guidance on whether your version requires an update or correction.
The recall affects the software used for treatment planning, which could impact treatment accuracy for patients. However, the specific risk is not described as causing immediate harm to patients.
Check your software version and contact RaySearch Laboratories for instructions on whether an update or correction is needed.
Look for software versions 6.1.1.2, 6.2.0.7, or 6.3.0.6 with service packs 1, 2, or 3. Lot codes starting with 0735000201008220170529, 0735000201007520170630, or 0735000201024220190923 indicate affected units.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1192-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1192-2025 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.
