Jun

2018

Recall – MRI Brain Analysis and Visualization Software

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

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Recall – MRI Brain Analysis and Visualization Software

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