BEUDAMED
    FDA Recall 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 · Initiated September 4, 2018

    Recall

    Recall Number
    Z-1216-2019
    Event Number
    82540
    Firm
    Alpha Omega Engineering
    FEI Number
    3001610756
    Product Code
    GZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 4, 2018
    Posted
    May 6, 2019
    Terminated
    November 3, 2020
    Address
    PO Box 810, Haavoda Street Nazerat Illit 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.

    Action

    The firm originally notified customers of the issue via email on September 4, 2018. Also, another updated notification Urgent Field Safety Notice, Neuro Omega system, DATE March 4, 2019, Field Advisory Note [FAN] Attention: Details on affected devices: Neuro Omega system with: Catalogue number: (Neuro Omega) NOM-000000-00 + (Drive) 750-000020-00 + (EMG) 750-000010-00 + (EEG) 750-000010-12 Software version number: Any, clarifying that the issue only occurred in a triple-fault condition.

    Distribution

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

    Quantity

    29