RaySearch Laboratories AB recalled 22 units of its radiation therapy treatment planning system on November 28, 2025. The recall affects software versions RayStation 11B and its updates due to a high hazard risk. The software may not invalidate calculated radiation doses correctly under certain conditions, potentially impacting 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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Affected model numbers include 12.0.0, 12.1.0, 12.0.3, 12.0.4, and 12.3.0. The software versions include RayStation 11B, 11B SP1, 11B SP2, 11B SP3, and 11B SPT1.
The software may fail to invalidate calculated radiation doses for certain Regions of Interest (ROIs) that lack contours or have specific material overrides. This failure presents a high risk of improper radiation dosing.
There have been no reported injuries or deaths related to this recall. However, the potential for incorrect treatment planning poses a significant risk.
Patients and healthcare providers must stop using the device immediately. Contact RaySearch Laboratories AB for recall instructions and guidance.
For more information, reach out to RaySearch Laboratories AB via email or visit their website. Additional details are available at the FDA recall link.
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