BEUDAMED
    FDA Recall 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 · Initiated August 20, 2018

    Recall

    Recall Number
    Z-3023-2018
    Event Number
    80529
    Firm
    NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
    FEI Number
    3006738448
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 20, 2018
    Terminated
    September 16, 2020

    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).

    Action

    The firm sent a letter explaining the issue by email to the consignees on 08/20/2018. The firm requested that the consignee check the stock without removing the device from the magnet. It is was not in the magnet room, safely quarantine the device, and respond to the recall notice. The firm also directed any consignee who further distributed the product to notify those entities and to contact NNL. NNL will follow-up with them directly. NNL will upgrade all existing models with a safer design of the LCD Power supply unit.

    Distribution

    worldwide

    Quantity

    163 units