medical Class II Updated 2018-06-13

NordicNeuroLab AS recalls nordicBrainEx 2.0 provides analysis and visualization capabi

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
Lot/Code Info: version 2.1 and older
View official government recall

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