Events

Recall of SmartEP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intelligent Hearing Systems Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54168
  • Event Risk Class
    Class 2
  • Event Number
    Z-1704-2010
  • Event Initiated Date
    2008-10-21
  • Event Date Posted
    2010-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87751
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    neurological hearing tester - Product Code GWJ
  • 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.

Device

SmartEP
  • Model / Serial
    IHS2195, IHS3048V, IHS3116, IHS3128V, IHS3182, IHS3420, IHS3431, IHS3443, IHS3485, IHS3545, IHS3563, IHS3565, IHS3580, IHS3591, IHS3642, IHS3665, IHS3668, IHS3683, IHS3829, IHS3878, IHS3967, IHS4001, IHS2209, IHS2281, IHS3110, IHS3324, IHS3410, IHS3426, IHS3460, IHS3542, IHS3548, IHS3623, IHS3638, IHS3787, IHS3961, IHS3011, IHS3387, IHS3429, IHS3432, IHS3494, IHS3593, IHS3619, IHS3704, IHS2184, IHS3008, IHS3248, IHS3314, IHS3819, IHS3893, IHS4040.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
  • Manufacturer
    Intelligent Hearing Systems Corp.

Manufacturer

Intelligent Hearing Systems Corp.
  • Manufacturer Address
    Intelligent Hearing Systems Corp., 6860 Sw 81st St, Miami FL 33143-7708
  • Manufacturer Parent Company (2017)
    Intelligent Hearing Systems Corp.
  • Source
    USFDA