Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

nordicBrainEX Recalled by NordicNeuroLab AS Due to When exporting merged results from the BOLD, DSC,...

Date: June 16, 2022
Company: NordicNeuroLab AS
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact NordicNeuroLab AS directly.

Affected Products

nordicBrainEX, software versions 2.21 through 2.3.10

Quantity: 243 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About NordicNeuroLab AS

NordicNeuroLab AS has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report