NordicNeuroLab AS recalls nordicBrainEX, software versions 2.21 through 2.3.10

Recall date

June 16, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1462-2022

FDA classification

Class II

Brand / firm

NordicNeuroLab AS

Sold / distributed

US Nationwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

nordicBrainEX, software versions 2.21 through 2.3.10