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NordicNeuroLab AS recalls nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the deri
Recalled June 13, 2018 · FDA recall Z-2050-2018 · NordicNeuroLab AS
Hazard
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. · FDA Class II
Units
22 licenses
Sold at
USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
Description
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.
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.
Manufacturer(s)
NordicNeuroLab AS
Made in
Norway
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →