RayStation Radiation Therapy Software Recall
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation
Updated November 28, 2025
RayStation radiation therapy planning software versions 17.0.0, 17.0.1 (RayStation v2025 and v2025 SP1) may fail to recalculate radiation doses correctly when certain regions of interest lack contours or have material overrides. This could result in patients receiving inaccurate radiation treatment plans.
Is the RAYSEARCH LABORATORIES AB recalled? Yes. This product was recalled by FDA on November 28, 2025. Details below.
What is recalled
RayStation/RayPlan versions 17.0.0 and 17.0.1, specifically RayStation v2025 and RayStation v2025 SP1 software, manufactured by RaySearch Laboratories AB.
Am I affected
You are affected if your cancer treatment center or hospital uses RayStation versions 17.0.0 or 17.0.1, or RayStation v2025 or v2025 SP1 software for radiation therapy planning. Check your facility's RayStation software version number.
What to do right now
Contact RaySearch Laboratories AB immediately to verify whether your RayStation installation is affected and obtain instructions for updating or correcting treatment plans. Do not proceed with radiation treatment plans generated by the affected software versions until the issue is resolved.
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.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1110-2026
- Classification
- Class II
- Recalled
- November 28, 2025
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