Class II — NordicNeuroLab AS
| Recalling firm | NORDICNEUROLAB AS |
|---|---|
| Registered facility | NORDICNEUROLAB AS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 22 licenses |
| Distribution | USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom |
| Initiated | 2014-09-17 |
| Classified | 2018-06-01 |
| Terminated | 2021-03-24 |
| Recall number | Z-2050-2018 |
| 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 — NordicNeuroLab AS (Z-2050-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78466/
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