RaySearch Laboratories recalls RayStation 11A software versions due to potential radiation dose calculation errors for certain treatment areas. Affected users should check their software version and 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 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 properly invalidate radiation dose calculations for certain treatment areas (ROIs) that have no contours or specific material overrides. This could result in incorrect radiation doses being delivered to patients during cancer treatment.
Radiation therapy professionals using RayStation 11A software versions 11.0.0 through 11.0.4 with specific lot codes and serial numbers. Patients receiving treatment with these software versions are at risk of incorrect radiation dosing.
Check if your software version is 11.0.0, 11.0.1, 11.0.3, or 11.0.4 with the specific lot codes and serial numbers listed in the recall notice. The software is used in radiation therapy treatment planning systems.
Verify your RayStation software version matches the recalled versions (11.0.0, 11.0.1, 11.0.3, 11.0.4).
Reach out to RaySearch Laboratories for guidance on updates or corrections to the software.
The recall indicates a potential risk for incorrect radiation dose calculations in specific treatment areas, but the software is not immediately dangerous. Patients should follow their treatment team's instructions.
Check your software version against the recalled versions (11.0.0, 11.0.1, 11.0.3, 11.0.4) and verify your lot code or serial number from the recall notice.
No, the recall does not require immediate discontinuation. Users should check their software version and contact RaySearch for updates.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1103-2026 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1103-2026 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.
