# FDA recall Z-2050-2018

> **NordicNeuroLab AS** · Class II · device recall initiated 2014-09-17.

## 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.

## Distribution

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

## Key facts

- **Recall number:** Z-2050-2018
- **Recalling firm:** NordicNeuroLab AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2014-09-17
- **Report date:** 2018-06-13
- **Termination date:** 2021-03-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bergen, N/A, Norway

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2018

## Citation

> AI Analytics. FDA recall Z-2050-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2050-2018. Source: US FDA. Licensed CC0.

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