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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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