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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RayStation is a radiation therapy treatment planning system designed to assist healthcare providers in calculating radiation doses for patients. It is commonly used in cancer treatment settings to optimize therapy plans.
The software contains a defect that may lead to incorrect dose calculations for certain Regions of Interest. This can occur when the ROIs have no contours or have specific material overrides, compromising patient treatment effectiveness.
This recall is not part of a broader industry pattern.
This recall poses a serious risk to patient safety, as incorrect radiation doses could lead to ineffective treatment or further complications.
Software version information can typically be found in the software settings or about section of the application.
Expect a refund processing timeline of approximately 4-6 weeks after submitting your request.
Keep copies of purchase receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
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.
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