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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1106-2026
- Classification
- Class II
- Recalled
- November 28, 2025
Get free recall alerts
New Medical Devices recalls, the moment they post.
Free forever. Unsubscribe anytime. We never sell your data.
More Medical Devices recalls
SUNS International SS6291 Elevator Switch Recall
SUNS International is recalling SS6291 Solenoid Interlock Switches used in residential elevators because the switch can get stuck in a retracted position, …
SUNS SS6291 Solenoid Interlock Switches
Residential Elevators StrikeLock Door Lock Recall
Residential Elevators is recalling its StrikeLock hoistway door locking device, used on residential elevator landing doors. The defective lock can allow the …
Residential Elevators StrikeLock Hoistway Door Locking Device
BD PurPrep Povidone-Iodine Recall
BD PurPrep povidone-iodine sterile skin prep solution (25 applicators per carton) may not be sterile due to potential product contamination. Using a non-sterile …
CareFusion 213, LLC