Neuro Kinetics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2730-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 21, 2015

Date Posted: September 9, 2015

Recall Number: Z-2730-2015

Event ID: 71832

Reason for Recall:

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

Status: Terminated

Product Quantity: 45

Code Information:

models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C, with S/N 890739 S/N 900140 S/N 900133 S/N 900114 S/N 900172 S/N 900136 S/N 900162 S/N 900134 S/N 900137 S/N 900147 S/N 890739 S/N 900140 S/N 900169 S/N 890738 S/N 900133 S/N 900118 S/N 900127 S/N 900138 S/N 900163 S/N 890742 S/N 890773 S/N 900155 S/N 900150 S/N 900158 S/N 900125 S/N 900123 S/N 900108 S/N 900114 S/N 900160 S/N 900168 S/N 900102 S/N 900130 S/N 900131 S/N 900128 S/N 900144 S/N 890741 S/N 890726 S/N 890736 S/N 900145 S/N 900111 S/N 900119

Distribution Pattern:

Worldwide Distribution - US (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated