RaySearch Laboratories AB recalled RayStation software on November 28, 2025, due to a malfunction. The software fails to invalidate calculated radiation doses for certain Regions of Interest. This defect poses a potential risk to patient safety.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for instructions. Notification method: E-Mail
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The RayStation software is used in radiation therapy treatment planning to calculate the optimal dose of radiation for patients. Healthcare providers rely on its accuracy for effective treatment.
The software's defect may lead to incorrect dosing, as it fails to invalidate calculations for certain Regions of Interest. This could result in patients receiving either too much or too little radiation.
This recall is not part of a broader industry pattern.
Patients relying on this software may face significant health risks due to potential incorrect radiation dosing. The urgency to stop using the software is high, impacting treatment schedules and patient safety.
You can find serial numbers and model numbers typically in the software settings or about page within the application.
Expect a timeline of 4-6 weeks for the processing of any refunds or replacements.
Keep records of all communication with the manufacturer, including emails and any provided recall instructions.
The recall affects RayStation/RayPlan software, model 16.0.0, version RayStation 2024B. The product is part of the Radiation Therapy Treatment Planning System and has no specific retail information available.
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