RaySearch recalls specific RayStation software versions due to potential radiation dose calculation errors for certain treatment areas in radiation therapy planning.
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 is recalling specific versions of its RayStation radiation therapy software (13.0.0.1547, 13.1.0.144, 13.1.1.89) because they may not correctly calculate radiation doses for some treatment areas. This could lead to incorrect radiation delivery during cancer treatment, potentially affecting patient safety.
The software may not correctly calculate radiation doses for certain treatment areas (ROIs) that have no contours, material overrides, or specific types like Bolus, Fixation, or Support. This could lead to incorrect radiation delivery during cancer treatment.
Radiation therapy professionals using RayStation software versions 13.0.0.1547, 13.1.0.144, or 13.1.1.89 are most at risk. Patients receiving treatment with these versions may be affected if the software fails to properly calculate radiation doses.
Check if your RayStation software version is 13.0.0.1547, 13.1.0.144, or 13.1.1.89. These versions were sold with the software revisions RayStation 12A, 12A SP1, or 12A SP2.
Identify your RayStation software version by checking the version number in the software interface.
The recall indicates a potential issue with radiation dose calculations for certain treatment areas, but it does not specify that patients are at immediate risk. The software may need correction to ensure accurate treatment.
The recall does not specify a remedy, so users should check their software version and contact RaySearch for guidance if they are using the affected versions.
Check if your RayStation software version is 13.0.0.1547, 13.1.0.144, or 13.1.1.89, which were sold with RayStation 12A, 12A SP1, or 12A SP2.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1105-2026 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1105-2026 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.
