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Recall Observatory FDA recall evidence

Device 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.

Z-2050-2018

September 17, 2014

Class II

Product summary

Firm
NordicNeuroLab AS
Event
Event 78466
Status
Terminated
Classification
Class II
Quantity
22 licenses
Official record key
device-enforcement:Z-2050-2018

Official wording

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.

Code information: version 2.1 and older

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.