The Recall Desk
ModerateFDA (Devices)·Z-0934-2021·Announced 2021-02-10

Brainreader Recalls Neuroreader Software Due to Database Discrepancy

Brainreader ApS is recalling Neuroreader Medical Image Processing Software Version 2.4 because it was distributed with a reference database different from the FDA-cleared version.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the hazard is a software configuration error rather than a direct physical danger like fire or choking.

Plain-English summary

Brainreader ApS is recalling Neuroreader Medical Image Processing Software, Version 2.4. The software is intended to automate the manual process of identifying, labeling, and quantifying the volume of segmentable brain structures on MR images.

The recall is being conducted because the software was distributed with a reference normative database that is different from the version reviewed and cleared by the FDA. This discrepancy means the software may not function as intended or validated by the agency.

The affected software was distributed nationwide in the United States, including in the states of UT, PA, FL, AL, CA, MN, MD, MO, VA, DC, IL, TX, TN, MI, NY, IN, WA, WI, GA, and MA. A total of 43 sites have had access to the recalled software. Users should contact Brainreader ApS for instructions on how to resolve the issue.

The recalled product

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
Brainreader ApS
Category
Medical Device — Software
Hazard
Affected units
43

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Version 2.4

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Related recalls

Same hazard · software error

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