BEUDAMED
    FDA Recall Terminated

    IELLIOS Product Usage: Muscle stimulation

    Recall: Z-1139-2012 · Initiated January 6, 2012

    Recall

    Recall Number
    Z-1139-2012
    Event Number
    61073
    Firm
    Ion Genius, Inc.
    FEI Number
    3003588228
    Product Code
    NFO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 6, 2012
    Posted
    March 1, 2012
    Terminated
    May 21, 2015
    Address
    7192 Kalanianaole Hwy, Ste D-204A, Honolulu, HI, 96825-1800

    Description

    IELLIOS Product Usage: Muscle stimulation

    Reason

    Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA

    Action

    Ion Genius sent a Medical Device Product Recall letters to all affected customers on January 6, 2012. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to check their inventory for the affected products and return immediately to Ion Genius for replacements. Customers returning affected products should call the firm so that a shipping label can be provided. Customers were instructed to be completed the Response Form and returned to Ion Genius by fax at 808-395-0787. For questions and concerns contact Xanya Sofra-Weiss at 808-222-2664 or email [email protected].

    Distribution

    Worldwide Distribution - (USA) Nationwide Distribution

    Quantity

    72 cables in total, amounts of other devices not reported