Brainreader recalls Neuroreader software version 2.4 due to FDA-cleared database mismatch. Users may face incorrect medical analysis results from outdated reference norms.
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Brainreader is recalling Neuroreader Medical Image Processing Software version 2:4 because it uses a reference database different from the FDA-approved version. This could lead to inaccurate brain structure measurements in medical imaging.
The software uses a reference database that doesn't match the FDA-reviewed version. This mismatch could cause incorrect measurements of brain structures in MRI scans, potentially affecting diagnosis accuracy.
Medical professionals using Neuroreader software for brain imaging analysis. Those who have purchased version 2.4 are most at risk.
Check if you have Neuroreader software version 2.4. The software is intended for automating manual brain structure analysis in medical imaging.
Verify your Neuroreader software version is 2.4 by checking the software's documentation or settings.
The Neuroreader software version 2.4 uses a reference database different from the FDA-approved version, which could cause inaccurate brain structure measurements.
Check your software version. If it's 2.4, you may need to update to a version that matches the FDA-cleared database.
The recall is for potential inaccurate medical analysis results, not direct injury risks. The hazard level is low risk.
We’ve drafted a message you can send Brainreader to request your refund or repair — edit it as you like.
Subject: Recall Z-0934-2021 — Brainreader Brainreader Hello, I own a Brainreader that is covered by recall Z-0934-2021 from Brainreader. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
