BEUDAMED
    FDA Enforcement Class II Terminated

    ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

    Recall: Z-0722-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0722-2020
    Event ID
    84270
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LIFELINES NEURO COMPANY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 1, 2020
    Initiation Date
    October 11, 2019
    Classification Date
    December 20, 2019
    Termination Date
    November 16, 2020
    Address
    900 E Main St, Louisville, KY, 40206, United States

    Description

    ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

    Reason

    Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.

    Code Info

    UDI: 0 0856310 00635 1 Lot Code: J380188 Model Number: PL00010-29.00-31.75.33.00-35.50-G

    Distribution

    US Nationwide distribution in the states of TX, TN, NC.

    Quantity

    8