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 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.
The software may not invalidate radiation doses as intended for certain ROIs that lack contours or have material overrides. This defect could lead to serious treatment inaccuracies, elevating the risk of improper radiation exposure.
There are currently no reported incidents of injuries or deaths associated with this software. The recall is classified as Class II, indicating a high hazard level.
Patients and healthcare providers must stop using the software immediately. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for further instructions.
For more information, contact RAYSEARCH LABORATORIES AB via email. Additional details can be found at the FDA's recall page.
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