Events

Recall of IPortal NOTC and VNG

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

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
    71264
  • Event Risk Class
    Class 2
  • Event Number
    Z-1795-2015
  • Event Initiated Date
    2015-04-30
  • Event Date Posted
    2015-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137167
  • 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
    Nystagmograph - Product Code GWN
  • Reason
    Complaints of system malfunction and unintended, sudden movement at start up. no injuries reported.
  • Action
    Neuro Kinetics sent a Field Correction Advisory letter dated April 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected product were instructed to contact Customer Service if a malfunction is encountered and not to use the device until it has been assessed and corrected by Nuerokinetics. Customers with questions should call 412-963-6649.

Device

IPortal NOTC and VNG
  • Model / Serial
    Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
  • Product Description
    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
  • Manufacturer
    Neuro Kinetics, Inc.

Manufacturer

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