Neuro Kinetics

3 recalls •

• Categories: Diagnostic Equipment, Infusion Pumps

Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

Class I - Dangerous

The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

Jul 21, 2015 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

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

Apr 30, 2015 Diagnostic Equipment Nationwide View Details →

Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

Class I - Dangerous

The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.

Nov 21, 2013 Infusion Pumps Nationwide View Details →