Neuroreader Medical Image Processing Software — Class II medical device recall Z-0934-2021
Terminated recall by Brainreader ApS, reported 2021-02-10, distributed nationwide. The Neuroreader has been distributed with a reference normative database that is different from the version re
| Recall number | Z-0934-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainreader ApS, Horsens, Denmark |
| Recall initiated | 2020-12-14 |
| Classified | 2021-01-29 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2021-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 43 sites |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0934-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.