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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RayStation is a software system used in radiation therapy treatment planning. It allows healthcare providers to plan and optimize treatment for cancer patients.
The software may fail to invalidate certain calculated radiation doses, especially for Regions of Interest lacking contours or having specific material overrides, leading to potential treatment inaccuracies.
This recall is not part of a broader industry pattern.
Patients and healthcare providers may face delays in treatment planning and need to implement alternative methods while awaiting further instructions.
Model and software version details can typically be found in the software's settings or about section.
Expect a refund or replacement to take approximately 4-8 weeks.
Keep copies of receipts, emails, and any correspondence regarding the recall for your records.
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.
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