RaySearch recalls RayStation software version 10B and 10B Service Pack 1 due to density uncertainty issues affecting radiation therapy treatment plans. Affected units may produce inaccurate treatment calculations for proton and light ion therapies.
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 RayStation software version 10B and 10B Service Pack 1 because density uncertainty errors could lead to inaccurate radiation treatment calculations for proton and light ion therapies. This affects medical professionals using the software for radiation therapy planning.
The software uses density uncertainty in radiation therapy calculations, which can cause errors when converting CT scan data to mass density. This affects the accuracy of treatment plans for proton and light ion therapies, potentially leading to incorrect radiation doses.
Medical professionals using RayStation software version 10B and 10B Service Pack 1 for radiation therapy treatment planning. Patients receiving proton or light ion therapy treatments may be at risk if the software produces inaccurate calculations.
Check for software version 10B or 10B Service Pack 1 with lot codes UDI: 0735000201031020201216 and 0735000201047120220128. The software may also be identified by GTIN numbers 07350002010310 and 07350002010471.
Verify your RayStation software version is 10B or 10B Service Pack 1 by checking the software settings or documentation.
The recall affects medical professionals using the software for treatment planning. Patients may be at risk if the software produces inaccurate calculations for their treatments.
Check for software version 10B or 10B Service Pack 1 with lot codes UDI: 0735000201031020201216 and 0735000201047120220128 or GTIN numbers 07350002010310 and 07350002010471.
The recall does not require immediate discontinuation. Users should check their software version and consider updating to a newer version if available.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1188-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1188-2025 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.
