Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brainlab ExacTrac Dynamic software Recalled by Brainlab AG Due to Deep Inspiration Breath Hold (DIBH) functionality may not...
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 Brainlab AG directly.
Affected Products
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Quantity: 56 systems in the U.S.
Why Was This Recalled?
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Brainlab AG
Brainlab AG has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report