BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-2050-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2050-2018
    Event ID
    78466
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NordicNeuroLab AS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 13, 2018
    Initiation Date
    September 17, 2014
    Classification Date
    June 1, 2018
    Termination Date
    March 24, 2021
    Address
    Mollendalsveien 65c, N/A, Bergen, N/A, N/A, Norway

    Description

    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.

    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 Info

    version 2.1 and older

    Distribution

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

    Quantity

    22 licenses