RaySearch Laboratories recalls RayStation 11B software versions due to potential radiation dose calculation errors for certain treatment planning regions. Affected units may need correction to ensure safe radiation therapy.
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
RaySearch Laboratories is recalling specific versions of their RayStation and RayPlan software due to a risk that radiation dose calculations might not work correctly for certain treatment areas. This could lead to incorrect radiation doses being delivered during cancer treatment, potentially affecting patient safety.
The software may fail to correctly calculate radiation doses for certain treatment regions (ROIs) that have no contours or specific material overrides. This could result in incorrect radiation delivery during cancer treatment, potentially affecting patient safety.
Radiation therapy professionals using RayStation 11B software versions 12.0.0 through 12.3.0 with specific model numbers and serial numbers. Patients receiving treatment with these software versions may be at risk if the dose calculation error occurs.
Check if your RayStation software version is 12.0.0, 12.1.0, 12.0.3, 12.0.4, or 12.3.0 with the specific model numbers listed in the recall notice. The software versions include RayStation 11B through 11B SPT1.
Verify your RayStation software version by checking the software version number in the program settings.
Reach out to RaySearch Laboratories for guidance on whether your software version is affected and if a fix is needed.
The recall addresses a potential issue with radiation dose calculations for certain treatment regions, but it does not indicate an immediate risk of serious injury. The hazard level is low risk.
Check your software version against the list provided in the recall notice. If affected, contact RaySearch Laboratories for further instructions.
Your software is affected if it is version 12.0.0, 12.1.0, 12.0.3, 12.0.4, or 12.3.0 with the specific model numbers listed in the recall notice.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1104-2026 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1104-2026 from RaySearch Laboratories. 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.
