Company: NordicNeuroLab AS
Date of Enforcement Report 6/13/2018
Class II:
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.. Recall Number: Z-2050-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
NordicNeuroLab AS, Bergen Norway on 9/17/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
22 licenses
DISTRIBUTION
Nationwide and Internationally