RaySearch recalls specific RayStation software versions (8B, 9A) due to density uncertainty errors in radiation therapy planning that could affect treatment accuracy. Affected users should check their software version and contact RaySearch for guidance.
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 (8B, 9A) because density uncertainty errors in these versions could lead to inaccurate treatment planning for proton and light ion therapy. This affects medical professionals using the software for radiation treatment planning.
The software versions 8B and 9A have inconsistencies in how density uncertainty is handled, which could lead to inaccurate treatment planning for proton and light ion therapy. This might cause errors in the radiation dose calculation, potentially affecting treatment outcomes.
Medical professionals using RayStation software versions 8B, 9A, and related service packs for radiation therapy treatment planning are most at risk. Patients receiving proton or light ion therapy treatments may be affected if their treatment plans were created using the recalled software versions.
Check if your RayStation software version is 8B, 9A, or includes service packs 1 and 2 for version 8B. Also, verify the software revision matches the listed versions (8.1.0.47, 8.1.1.8, etc.) or the lot codes and serial numbers provided in the recall notice.
Identify your RayStation software version by checking the version number in the software interface or documentation.
Reach out to RaySearch Laboratories for guidance on whether your version is affected and what steps to take next.
The recall affects the software used for treatment planning, which could impact patients receiving proton or light ion therapy if their treatment plans were created with the recalled software versions. However, patients themselves are not directly affected by the software recall.
Check your software version in the RayStation interface or documentation. Affected versions include 8B, 9A, and specific model numbers like 8.1.0.47, 8.1.1.8, and 9.0.0.113.
The recall does not require immediate updates; however, you should contact RaySearch to determine if your version is affected and follow their guidance.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1186-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1186-2025 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.
