Neuro Kinetics, Inc. recalls I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of t

Recalled June 24, 2015 · FDA recall Z-1795-2015 · Neuro Kinetics

Hazard

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

Units

140

Sold at

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

Description

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

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.

Manufacturer(s)

Neuro Kinetics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →