Home / Recalls / Neuro Kinetics, Inc. / Z-1795-2015

Z-1795-2015 Class II Terminated

Recalled by Neuro Kinetics, Inc. — Pittsburgh, PA

FDA device recall Z-1795-2015 was initiated by Neuro Kinetics, Inc. on April 30, 2015 and is designated Class II. Reason for recall: complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. The recall status is terminated (terminated April 17, 2017). Affected quantity: 140.

Recall Details

Product Type: Devices
Report Date: June 24, 2015
Initiation Date: April 30, 2015
Termination Date: April 17, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 140

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.

Distribution Pattern

Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.

Code Information

Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3