Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Raystation treatment planning system for radiation therapy Recalled by RAYSEARCH LABORATORIES AB Due to It is possible to set a non-zero collimator...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RAYSEARCH LABORATORIES AB directly.
Affected Products
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
Quantity: 10770 systems
Why Was This Recalled?
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About RAYSEARCH LABORATORIES AB
RAYSEARCH LABORATORIES AB has 113 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report