Recall Z-1795-2015— Neuro Kinetics, Inc.

Name: FDA recall Z-1795-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-30

Class II · Terminated

Class II FDA medical device recall by Neuro Kinetics, Inc., initiated 2015-04-30, terminated 2017-04-17. It names one FDA 510(k) clearance: K083603. Product: 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.. Reason: complaints of system malfunction and unintended, sudden movement at start up. No injuries reported..

Recalling firm: Neuro Kinetics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-30
Terminated: 2017-04-17
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

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.

Reason for recall

complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

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