Brainreader ApS recalls Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of ident…

Recall date

December 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0934-2021

FDA classification

Class II

Brand / firm

Brainreader ApS

Sold / distributed

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.

Why it was recalled

The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.