RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation…

Recall date

November 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1103-2026

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System