NordicNeuroLab AS recalls nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the der…

Recall date

September 17, 2014

Source

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

Recall number

Z-2050-2018

FDA classification

Class II

Brand / firm

NordicNeuroLab AS

Sold / distributed

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

Why it was recalled

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.

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 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.