Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current m...
FDA Recall #Z-0934-2021 — Class II — December 14, 2020
Product Description
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.
Reason for Recall
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Recalling Firm
Brainreader ApS — Horsens
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
43 sites have had access
Distribution
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.
Code Information
Version 2.4
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated