Events

Recall of Device Recall Normative Data Template CD

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
    66995
  • Event Risk Class
    Class 2
  • Event Number
    Z-0966-2014
  • Event Initiated Date
    2013-11-21
  • Event Date Posted
    2014-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124458
  • 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
    The data provided on the normative data template cd for use with the i-portal devices has not received clearance by fda through the premarket 510(k) notification process.
  • Action
    A recall notification letter, dated November 2013, was sent to Users. A follow up letter regarding scheduling removal of the software is planned for December 2013.

Device

Device Recall Normative Data Template CD
  • Model / Serial
    Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed USA (nationwide) and the country of Canada.
  • Product Description
    Normative Data Template CD for use with the I-Portal devices. || Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
  • 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