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Brainreader ApS recalls Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identi
Recalled February 10, 2021 · FDA recall Z-0934-2021 · Brainreader ApS
Hazard
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA. · FDA Class II
Units
43 sites have had access
Sold at
US Nationwide distribution including in the states of UT, PA, FL, AL, CA, MN, MD, MO, VA, DC, IL, TX, TN, MI, NY, IN, WA, WI, GA, MA.
Description
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Product
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.
Manufacturer(s)
Brainreader ApS
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →