BEUDAMED
    FDA Enforcement Class II Terminated

    nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

    Recall: Z-2044-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-2044-2018
    Event ID
    78463
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NordicNeuroLab AS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 6, 2018
    Initiation Date
    September 12, 2014
    Classification Date
    May 31, 2018
    Termination Date
    October 6, 2020
    Address
    Mollendalsveien 65c, N/A, Bergen, N/A, N/A, Norway

    Description

    nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

    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 2.3.14

    Distribution

    Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.

    Quantity

    97 licenses