Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RayStation Radiation Therapy Treatment Planning System Recalled by RAYSEARCH LABORATORIES AB Due to The dose calculation accuracy may in some situations...
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 Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Quantity: 728
Why Was This Recalled?
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
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