FDANovember 28, 2025device

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

raysearch laboratories abraysearchraysearch laboratories

UPCs

0735000201076107350002010808

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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