Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Recalled by Brainlab AG Due to In case of a failed automatic marker detection,...
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
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Quantity: 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Why Was This Recalled?
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Where Was This Sold?
This product was distributed to 8 states: AZ, AR, CA, IN, NJ, NY, NC, OR
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