Recall Z-0966-2014— Neuro Kinetics, Inc.

Name: FDA recall Z-0966-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-21

Class II · Terminated

Class II FDA medical device recall by Neuro Kinetics, Inc., initiated 2013-11-21, terminated 2015-07-20. It names one FDA 510(k) clearance: K083603. Product: 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.. 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..

Recalling firm: Neuro Kinetics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Terminated: 2015-07-20
Firm location: Pittsburgh, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K083603 — I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOLNeuro Kinetics·cleared 2009-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.