RaySearch Laboratories recalled its RayStation and RayPlan software on November 28, 2025. The software fails to invalidate calculated radiation doses for certain Regions of Interest, posing a high risk to patients. Healthcare providers must stop using the device and follow recall instructions 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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Models affected include RayStation/RayPlan versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89. The software versions include RayStation 12A, RayStation 12A SP1, and RayStation 12A SP2. The products were distributed to various healthcare providers.
The software may fail to invalidate radiation doses for Regions of Interest that lack contours or have certain material overrides. This defect can lead to inaccurate treatment planning, endangering patient safety.
There have been no reported incidents or injuries associated with the software's failure to invalidate radiation doses. The recall is proactive to prevent potential risks.
Stop using the software immediately. Contact RaySearch Laboratories AB for further instructions and follow the provided recall guidelines.
For questions, contact RaySearch Laboratories AB via email. More information is available on the FDA website.
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