RaySearch recalls RayStation 2024B software version 16.0.0 due to potential radiation dose calculation errors for certain treatment areas. Affected users should contact RaySearch for updates.
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 RayStation 2024B software version 16.0.0 because it may not correctly calculate radiation doses for some treatment areas. This could lead to improper radiation delivery during cancer treatments, which is serious but not immediately dangerous.
The software may fail to properly calculate radiation doses for certain treatment areas (ROIs) that have no contours or specific material overrides. This could result in incorrect radiation delivery during cancer treatments, potentially affecting treatment safety.
Healthcare professionals using RayStation software for radiation therapy planning are most at risk. Patients receiving treatment with this software version could be affected if the dose calculation is incorrect.
Check if you have RayStation software version 16.0.0 (RayStation 2024B) installed. The software was sold between 2024 and 2029, with an expiration date of June 28, 2029.
Verify your RayStation version by checking the software menu or documentation.
Reach out to RaySearch Laboratories for guidance on next steps and potential fixes.
The recall indicates a potential risk for incorrect radiation dose calculations, which could affect treatment safety. However, the exact impact depends on specific usage conditions.
Check for RayStation software version 16.0.0 (RayStation 2024B) installed, which was sold between 2024 and 2029 with an expiration date of June 28, 2029.
No, but you should check your version and contact RaySearch for guidance as the issue may require specific actions to resolve safely.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1109-2026 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1109-2026 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.
