RaySearch recalls specific RayStation software versions (9B, 10A) due to density uncertainty errors in proton treatment planning. Affected users should verify their software version and 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 Laboratories is recalling specific versions of their RayStation radiation therapy software. The issue involves inconsistent density uncertainty calculations that could lead to inaccurate treatment planning for proton and light ion therapies. This affects medical professionals using the software for radiation treatment planning.
The software uses a calibration curve for converting CT scans to mass density, but inconsistencies in this process can cause errors in radiation dose calculations. This risk is specific to proton and light ion treatment planning where precise density measurements are critical for safety.
Medical professionals using RayStation software versions 9B, 9A Service Pack 1, 10A, and 10A Service Packs 1 and 2 for radiation therapy treatment planning. Patients receiving proton or light ion treatments may be at risk if the software is used incorrectly.
Check your RayStation software version (9B, 10A) and service packs. The affected versions include specific model numbers and serial numbers listed in the recall notice. Verify your software version by checking the 'About' section in RayStation.
Open RayStation and check the software version in the 'About' section to confirm if it is affected (9B, 10A, or 10A Service Packs 1/2).
Reach out to RaySearch Laboratories for guidance on updates or corrections if your software version is affected.
RayStation versions 9B, 9B Service Pack 1, 10A, and 10A Service Packs 1 and 2.
Check the software version in RayStation's 'About' section. Affected versions include 9B, 10A, and specific service packs listed in the recall notice.
No. The recall involves a software update, not an immediate stop-use requirement. Users should check their version and contact RaySearch for next steps.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1187-2025 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1187-2025 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.
