FDA Device recall Z-0934-2021
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, an…
- FDA Device
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, an… by Brainreader Aps, citing the Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0934-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-14 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Brainreader Aps |
| Distribution | US |
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
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Identifiers
| code_info | Version 2.4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2021%22
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