BEUDAMED
    FDA Recall Terminated

    Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016

    Recall: Z-1704-2010 · Initiated October 21, 2008

    Recall

    Recall Number
    Z-1704-2010
    Event Number
    54168
    Firm
    Intelligent Hearing Systems Corp.
    FEI Number
    1000113738
    Product Code
    GWJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 21, 2008
    Posted
    May 27, 2010
    Terminated
    September 21, 2011
    Address
    6860 Sw 81st St, Miami, FL, 33143-7708

    Description

    Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016

    Reason

    This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions

    Action

    Intelligent Hearing Systems sent a letter "Information Regarding the Discontinued Use of the SmartEP Evoked Response System for Vestibular Evoked Myogenic Potentials (VEMP) Testing" dated September 30, 2008 to customers and distributors. Each customer will receive an upgrade and VEMP removal kit which will remove the VEMP feature.

    Distribution

    Nationwide distribution.

    Quantity

    50