nordicBrainEX — Class II medical device recall Z-1462-2022
Terminated recall by NordicNeuroLab AS, reported 2022-08-03, distributed nationwide. When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay an
| Recall number | Z-1462-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, Norway |
| Recall initiated | 2022-06-16 |
| Classified | 2022-07-25 |
| Reported by FDA | 2022-08-03 |
| Terminated | 2024-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 243 units |
| UPC / GTIN / UDI-DI | 07090042059015 |
Product
nordicBrainEX, software versions 2.21 through 2.3.10
Reason for recall
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
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-1462-2022. 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.