BEUDAMED
    FDA Enforcement Class II Terminated

    fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1

    Recall: Z-3023-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3023-2018
    Event ID
    80529
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NordicNeuroLab AS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 19, 2018
    Initiation Date
    August 20, 2018
    Classification Date
    September 11, 2018
    Termination Date
    September 16, 2020
    Address
    Mollendalsveien 65c, N/A, Bergen, N/A, N/A, Norway

    Description

    fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1

    Reason

    Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).

    Code Info

    Serial numbers: LPS-2011-1.0-XXX LPS-2012-1.0-XXX LPS-2012-1.1-XXX LPS-2013-1.1-XXX

    Distribution

    worldwide

    Quantity

    163 units