Lower riskMedical device recall · FDA · Published December 14, 2020
Brainreader Neuroreader Software Recall: FDA Database Mismatch Risk
Brainreader recalls Neuroreader software version 2.4 due to FDA-cleared database mismatch. Users may face incorrect medical analysis results from outdated reference norms.
“Brainreader Neuroreader Software Recall: FDA Database Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63671-brainreader-neuroreader-software-recall-fda-database-mismatch-risk. Based on FDA recall #Z-0934-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2021%22&limit=1).
Brainreader ApS recalled Neuroreader Medical Image Processing Software Version 2.4 because it was distributed with a reference normative database different from the version reviewed and cleared by the FDA, according to the FDA. The recall was announced on December 14, 2020.
How to tell if you have it
Brand: Brainreader
Product: Neuroreader Medical Image Processing Software
Version: 2.4
The hazard
The FDA stated the hazard is that the Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by the FDA.
Context
GovInfoNow's records show other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter System Recall (2026-07-29), Philips Achieva 3.0T Recalled (2026-08-21), and GE Healthcare Enterprise Archive V8 Software Recall (2026-07-31).
How to tell if you have this one
Check if you have Neuroreader software version 2.4. The software is intended for automating manual brain structure analysis in medical imaging.
Brand
Brainreader
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Neuroreader software version is 2.4 by checking the software's documentation or settings.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0934-2021 (December 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0934-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.