Events

Recall of Device Recall VEST 6.6 or earlier software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neuro Kinetics.

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
    52961
  • Event Risk Class
    Class 2
  • Event Number
    Z-2253-2009
  • Event Initiated Date
    2009-07-24
  • Event Date Posted
    2009-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84337
  • 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
    VEST 6.6 or earlier software - Product Code LXV
  • Reason
    Marketed without a 510k or pma submission to include the normative data display.
  • Action
    A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance. Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.

Device

Device Recall VEST 6.6 or earlier software
  • Model / Serial
    Software versions 6.6 or earlier.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of AL, AZ, CA, DC, FL, GA, HI, IN, MA, MD, MI, MN, NC, NY, OR, PA, SC, TN, UT, VA, WA, and WV), Korea, United Kingdom, and Spain.
  • Product Description
    VEST 6.6 or earlier software for use with Neuro Kinetics products. || The device is used for vestibular testing.
  • Manufacturer
    Neuro Kinetics

Manufacturer

Neuro Kinetics
  • Manufacturer Address
    Neuro Kinetics, 128 Gamma Dr, Pittsburgh PA 15238-2920
  • Manufacturer Parent Company (2017)
    Neuro Kinetics Inc.
  • Source
    USFDA