Brainreader ApS: Medical Device Recall in 2021 - (Recall #: Z-0934-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 14, 2020

Date Posted: February 10, 2021

Recall Number: Z-0934-2021

Event ID: 86995

Reason for Recall:

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

Status: Terminated

Product Quantity: 43 sites have had access

Code Information:

Version 2.4

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated