BEUDAMED
    FDA Enforcement Class II Terminated

    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

    Recall: Z-2103-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2103-2018
    Event ID
    78848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NordicNeuroLab AS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    October 28, 2017
    Classification Date
    June 6, 2018
    Termination Date
    March 31, 2021
    Address
    Mollendalsveien 65c, N/A, Bergen, N/A, N/A, Norway

    Description

    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

    Reason

    Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

    Code Info

    HPS-2015-1.0-XXX HPS-2016-1.0-XXX

    Distribution

    Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria

    Quantity

    64 units