RaySearch recalls RayStation 6.0.0.24 software due to density uncertainty issues affecting radiation therapy treatment plans. Affected units may produce inaccurate dose calculations for 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 is recalling a specific version of its radiation therapy software (RayStation 6.0.0.24) because it can cause inconsistent density calculations. This might lead to inaccurate radiation treatment plans for proton and light ion therapies, potentially affecting patient safety.
The software version uses a density calibration curve that can cause inconsistencies in radiation dose calculations for proton and light ion treatments. This may result in incorrect treatment plans that could affect patient safety.
Healthcare providers using RayStation 6.0.0.24 for radiation therapy planning are affected. Patients receiving proton or light ion treatments using this software version are at risk of inaccurate dose calculations.
Check for RayStation software version 6.0.0.24 with serial numbers starting with 6.0.0.24. The software was sold between 2021 and 2024 with an expiration date of December 22, 2021.
Verify your RayStation version by checking the software version number in the application settings.
The recall indicates a potential risk of inaccurate dose calculations for proton and light ion treatments, but the official notice does not specify if this has caused injuries.
Check for RayStation version 6.0.0.24 with serial numbers starting with 6.0.0.24. The software was sold between 2021 and 2024 with an expiration date of December 22, 2021.
The official recall notice does not specify a remedy, so there is no action required at this time.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1193-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1193-2025 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.
