# FDA recall Z-0934-2021

> **Brainreader ApS** · Class II · device recall initiated 2020-12-14.

## 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0934-2021
- **Recalling firm:** Brainreader ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-14
- **Report date:** 2021-02-10
- **Termination date:** 2021-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsens, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2021

## Citation

> AI Analytics. FDA recall Z-0934-2021. Retrieved 2026-08-21 from https://api.ai-analytics.org/recall/Z-0934-2021. Source: US FDA. Licensed CC0.

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