Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Recalled by Brainlab AG Due to Brainlab Ultrasound Navigation Software does not support the...
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
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Quantity: 271 units
Why Was This Recalled?
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
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