BEUDAMED
    FDA Enforcement Class I Terminated

    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

    Recall: Z-1216-2019 · Reported May 15, 2019

    Enforcement

    Recall Number
    Z-1216-2019
    Event ID
    82540
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alpha Omega Engineering
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 15, 2019
    Initiation Date
    September 4, 2018
    Classification Date
    May 6, 2019
    Termination Date
    November 3, 2020
    Address
    PO Box 810, Haavoda Street, N/A, Nazerat Illit, N/A, N/A, Israel

    Description

    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

    Reason

    If cables are improperly connected, current may reach high charge density, causing tissue harm.

    Code Info

    Serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.

    Distribution

    US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA

    Quantity

    29