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

Recall date

April 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1795-2015

FDA classification

Class II

Brand / firm

Neuro Kinetics, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.