RaySearch Laboratories AB recalled its RayStation/RayPlan software on November 28, 2025, due to potential inaccuracies in radiation dose calculations. The issue affects certain Regions of Interest (ROIs) and could lead to incorrect treatment planning. Healthcare providers and patients should stop using the software immediately.
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/RayPlan software is used in radiation therapy treatment planning, helping healthcare providers calculate radiation doses for patients. Its accuracy is critical for safe and effective treatment.
The software may fail to invalidate radiation doses correctly when certain conditions are met, which could lead to dangerous treatment errors. This defect particularly affects ROIs with no contours or specific material overrides.
This recall is not part of a broader industry pattern.
Healthcare providers and patients face significant safety risks due to potential inaccuracies in treatment planning, which could lead to improper radiation exposure.
You can find the software version and model number in the software settings or installation documentation.
Expect a response from the manufacturer within 4-6 weeks regarding the recall and any potential fixes.
Keep records of all correspondence regarding the recall, including emails and any instructions received.
The recall affects RayStation/RayPlan software version 10B, model number 10.1, and UDI: 0735000201031020201216. The product was distributed to healthcare providers but specific retailers are not listed.
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