nordicBrainEx 2 — Class II medical device recall Z-2050-2018
Terminated recall by NordicNeuroLab AS, reported 2018-06-13. An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientat
| Recall number | Z-2050-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NordicNeuroLab AS, Bergen, N/A, Norway |
| Recall initiated | 2014-09-17 |
| Classified | 2018-06-01 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2021-03-24 |
| Countries outside the US | ES, GB, HU, IN, IS, IT, KR, NO, RU, SE |
| Quantity | 22 licenses |
| Reason classes | labeling |
Product
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Reason for recall
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
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-2050-2018. 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.