RaySearch Laboratories AB recalled RayStation software on November 28, 2025, due to a dose calculation error. The issue affects models 17.0.0 and 17.0.1, posing a high hazard to patients. Healthcare providers should stop using the software immediately and follow the recall instructions.
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 is a radiation therapy treatment planning system used in healthcare settings for planning radiation doses. It aids healthcare providers in delivering precise therapeutic doses to patients.
The software's failure to invalidate dose calculations for certain ROIs can lead to incorrect treatment plans, potentially affecting patient safety.
This recall is not part of a broader industry pattern.
Patients relying on this software for radiation therapy may face significant safety risks due to potential dose calculation errors.
Software version information can typically be found in the settings or about section of the application.
Expect to receive instructions from RAYSEARCH LABORATORIES AB within a few days after reporting the recall.
Keep records of any correspondence with the manufacturer and document the software version you are using.
The recall affects RayStation/RayPlan software versions 17.0.0 and 17.0.1, specifically RayStation v2025 and RayStation v2025 SP1. The affected products are distributed under Lot Code: UDI: 0735000201082220250423 and 0735000201094520250702.
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