RaySearch recalls RayStation 10B software version that may invalidate radiation dose calculations for certain treatment areas, risking incorrect radiation therapy doses. 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 recalls RayStation 10B software version 10.1.1 due to potential radiation dose calculation errors for specific treatment areas. This could lead to incorrect radiation therapy doses if the software fails to properly invalidate dose calculations for certain regions.
The software may fail to correctly invalidate radiation dose calculations for certain regions of interest (ROIs) that have no contours, material overrides, or specific types like Bolus, Fixation, or Support. This could result in incorrect radiation doses being delivered during treatment.
Radiation therapy treatment planning software users who have RayStation 10B software version 10.1.1. Patients and medical staff using this software for radiation therapy planning are most at risk.
Check if you have RayStation software version 10.1.1 (RayStation 10B SP1) for radiation therapy treatment planning. The software was sold with a serial number starting with 10.1.1.54 and expires in February 2027.
Verify your RayStation software version is 10.1.1 (RayStation 10B SP1) by checking the software's version information.
RayStation 10B software version 10.1.1 (RayStation 10B SP1).
The software may have incorrect radiation dose calculations for certain regions of interest (ROIs) with no contours, material overrides, or specific types like Bolus, Fixation, or Support.
The recall record does not specify a remedy, so contact RaySearch directly for guidance.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1107-2026 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1107-2026 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.
