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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RayStation is a radiation therapy treatment planning system used by healthcare providers to calculate and deliver accurate radiation doses to patients. It is crucial for ensuring effective treatment in cancer therapies.
The software's failure to accurately invalidate a calculated radiation dose for certain Regions of Interest can lead to improper treatment planning, potentially endangering patient health.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients relying on accurate dosing for radiation therapy, emphasizing the urgency for immediate action to prevent potential health risks.
Software versions can typically be found in the application settings or about section of the software.
Refund or replacement processing typically takes 4-8 weeks.
Keep records of your purchase, any communications regarding the recall, and screenshots of the software version.
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.
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