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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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.
The software may not invalidate calculated radiation doses for certain Regions of Interest (ROIs). This defect occurs for ROIs without contours, particularly those with defined material overrides or of type Bolus, Fixation, or Support.
There have been no reported injuries or deaths associated with this issue. The potential for incorrect dose calculation poses a high risk to patient safety.
Stop using the RayStation software immediately. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for further instructions.
For more information, contact RAYSEARCH LABORATORIES AB via email or visit the FDA website for detailed recall instructions.
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