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Neuro Kinetics Recalls
3 recalls on record · February 19, 2014 to September 9, 2015 · Medical Devices
Recalls by year
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 9, 2015Medical DevicesFDA
Neuro Kinetics, Inc. recalls Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular a
Hazard: The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
June 24, 2015Medical DevicesFDA
Neuro Kinetics, Inc. recalls I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of t
Hazard: complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
February 19, 2014Medical DevicesFDA
Neuro Kinetics, Inc. recalls Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involu
Hazard: 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.