Reported Jun 24, 2015 · Terminated

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

Neuro Kinetics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neuro Kinetics, Inc. · 128 Gamma Dr · Pittsburgh, PA · 15238-2920

Is this the product you have?

  • 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.
Lot codes and dates
  • Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3
Amount recalled
140

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 17, 2017 · Data as of Sep 19, 6:15 PM UTC

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