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High risk Medical DevicesClass II

RayStation Radiation Therapy Software Recall

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, Ray

Updated November 28, 2025

RayStation radiation therapy planning software versions 14.0.0, 15.0.0, 15.1.3, and certain 2023B/2024A variants may fail to properly recalculate radiation doses when modifying certain regions of interest, potentially leading to incorrect treatment plans. This affects specific regions that lack contours and have material overrides or are designated as Bolus, Fixation, or Support types.

Is the RAYSEARCH LABORATORIES AB recalled? Yes. This product was recalled by FDA on November 28, 2025. Details below.

What is recalled

RayStation/RayPlan software versions: 14.0.0, 15.0.0, 15.1.3, RayStation 2023B, RayStation 2024A, and RayStation 2024A SP3, manufactured by RaySearch Laboratories AB.

Am I affected

You're affected if you use RayStation radiation therapy planning software and have installed version 14.0.0, 15.0.0, 15.1.3, RayStation 2023B, RayStation 2024A, or RayStation 2024A SP3.

What to do right now

Contact RaySearch Laboratories AB immediately to report your use of this software and obtain a corrected version. Do not rely on dose calculations for regions of interest without contours that have material overrides or are designated as Bolus, Fixation, or Support types until you have received an updated version.

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

RAYSEARCH LABORATORIES AB
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1106-2026
Classification
Class II
Recalled
November 28, 2025
Read the official notice

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