RaySearch recalls RayStation software versions 7.0.0.19 and 8.0.0.61 due to density uncertainty errors affecting proton treatment plans. Affected users should contact RaySearch for updates.
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 specific versions of its RayStation radiation therapy software because density uncertainty errors could lead to inaccurate treatment plans for proton and light ion therapies. This affects medical professionals using these software versions for radiation treatment planning.
The software uses density uncertainty calculations that can become inconsistent when converting CT scans to mass density for proton and light ion treatments. This inconsistency may result in incorrect radiation dose calculations, potentially affecting treatment accuracy.
Medical professionals using RayStation software versions 7.0.0.19, 8.0.0.61, and 8.0.1.10 for radiation therapy planning are most at risk. Patients receiving proton or light ion treatments may be impacted if the software is used incorrectly.
Check if your RayStation software version is 7.0.0.19, 8.0.0.61, or 8.0.1.10. The software was sold with specific lot codes and expiration dates listed in the recall notice.
Reach out to RaySearch Laboratories for guidance on the recall and potential software updates.
The recall indicates a potential risk in treatment planning accuracy, but the official notice does not specify patient safety impacts.
Software versions 7.0.0.19, 8.0.0.61, and 8.0.1.10 are affected.
Check your software version against the list of affected versions provided in the recall notice.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1185-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1185-2025 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.
