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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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.
The software may fail to invalidate calculated radiation doses for certain Regions of Interest that lack contours or have defined material overrides. This defect could lead to inaccurate radiation treatment.
No specific incidents or injuries have been reported related to this software issue. Health risks could arise from incorrect radiation doses.
Stop using the RayStation software immediately. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for further instructions and notifications via email.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1108-2026 or contact RAYSEARCH LABORATORIES AB directly.
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