RaySearch Laboratories recalled RayStation software on November 28, 2025, due to a potential error in calculating radiation doses. The recall affects 119 units of software versions 14.0.0, 15.0.0, and 15.1.3. Healthcare providers should stop using the software immediately to ensure patient safety.
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 impacts RayStation and RayPlan software versions 14.0.0, 15.0.0, 15.1.3, RayStation 2023B, RayStation 2024A, and RayStation 2024A SP3. The software was distributed to healthcare facilities in the United States and other countries.
The software may incorrectly calculate radiation doses for certain Regions of Interest (ROIs). This issue particularly affects ROIs that lack contours and either have material overrides defined or are classified as Bolus, Fixation, or Support.
There are no reported injuries or deaths associated with this recall. The potential for miscalculated doses poses a significant risk to patient safety.
Stop using the affected software immediately. Contact RaySearch Laboratories AB or your healthcare provider for further instructions on how to proceed.
For further information, contact RaySearch Laboratories AB via email. Visit the FDA recall page for additional details.
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