RaySearch Laboratories recalls RayStation/RayPlan 10B software due to potential radiation dose calculation errors for certain ROI types. Affected users should contact the company for remediation.
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 RayStation/RayPlan software version 10B because it may not correctly calculate radiation doses for some types of treatment areas. This could lead to improper radiation delivery during cancer therapy.
The software may not 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 treatment.
Radiation therapy treatment planning software users who have RayStation/RayPlan 10B software. Patients and medical staff using this software for cancer treatment are most at risk.
Check for software version 10B with model number 10.1. The software was sold for radiation therapy treatment planning and expires February 2027.
Reach out to RaySearch Laboratories for guidance on fixing the software issue.
The software may not calculate radiation doses correctly for certain treatment areas, but it does not cause immediate harm. Users should contact RaySearch for remediation.
Check for software version 10B with model number 10.1. The software was sold for radiation therapy treatment planning and expires February 2027.
Contact RaySearch Laboratories for guidance on fixing the software issue.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1102-2026 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1102-2026 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.
