Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Neuroreader Medical Image Processing Software - Product Usage: intended to Recalled by Brainreader ApS Due to The Neuroreader has been distributed with a reference...
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 Brainreader ApS directly.
Affected Products
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.
Quantity: 43 sites have had access
Why Was This Recalled?
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Brainreader ApS
Brainreader ApS has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report