# FDA recall Z-1462-2022

> **NordicNeuroLab AS** · Class II · device recall initiated 2022-06-16.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1462-2022
- **Recalling firm:** NordicNeuroLab AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-16
- **Report date:** 2022-08-03
- **Termination date:** 2024-09-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2022

## Citation

> AI Analytics. FDA recall Z-1462-2022. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1462-2022. Source: US FDA. Licensed CC0.

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