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 | nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric … |
| Quantity | 16 licenses |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece |
| Initiated | 2014-12-15 |
| Classified | 2018-05-31 |
| Terminated | 2021-03-24 |
| Recall number | Z-2042-2018 |
| 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-2042-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78460/
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