RaySearch Laboratories recalled a radiation therapy treatment planning system on November 28, 2025. The recall affects 10 units of RayStation software versions 11.0.0, 11.0.1, 11.0.3, and 11.0.4. The system may inaccurately calculate radiation doses for certain Regions of Interest, posing a high risk to patients.
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 includes the RayStation software versions 11.0.0, 11.0.1, 11.0.3, and 11.0.4. Model numbers include Lot Code UDI: 0735000201038920210518 and others. The software was distributed before the recall date.
The radiation therapy software may fail to invalidate calculated radiation doses for certain Regions of Interest that lack contours or have specific material overrides. This malfunction can lead to ineffective treatment and poses a high risk to patient safety.
Stop using the affected software immediately. Follow the manufacturer's recall instructions and contact RaySearch Laboratories or your healthcare provider for further guidance.
For more information, contact RaySearch Laboratories AB via email. Visit the FDA website for additional details on the recall.
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