Class II — Brainreader ApS
| Recalling firm | Brainreader A/S |
|---|---|
| Registered facility | Brainreader (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA. |
| 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. |
| Quantity | 43 sites have had access |
| 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. |
| Initiated | 2020-12-14 |
| Classified | 2021-01-29 |
| Terminated | 2021-08-12 |
| Recall number | Z-0934-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Brainreader ApS (Z-0934-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86995/
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