RaySearch Laboratories recalled RayStation software on November 28, 2025, due to a serious issue with dose calculation. The software, used in radiation therapy, may not invalidate calculated doses for certain Regions of Interest. Healthcare providers and patients should stop using this 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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RayStation software assists healthcare providers in planning radiation therapy treatments. It is critical for ensuring accurate radiation dose calculations during patient treatment.
The software may incorrectly retain doses for certain Regions of Interest, leading to potentially unsafe treatment plans. This could result in patients receiving inadequate or excessive radiation.
This recall is not part of a broader industry pattern.
Patients relying on accurate radiation therapy planning may face increased health risks if the software remains in use. Immediate action is necessary to ensure patient safety.
Software version and model numbers can typically be found in the software's settings or about section.
Expect a response regarding refunds or further instructions within 4-6 weeks after contacting the manufacturer.
Keep records of all correspondence with the manufacturer, including emails and any receipts or documentation related to the purchase.
The recall affects RayStation models 15.2.0 and 15.1.3, as well as software versions RayStation 2024A SP1 and RayStation 2024A SP2. The software is used for radiation therapy treatment planning. No price information is available.
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