FDA Device recall Z-2730-2015

Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test

FDA Device
Class II
terminated
Published 2015-09-09

On 2015-09-09 the FDA classified a Class II recall of Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test by Neuro Kinetics, citing the devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2730-2015
Classification	Class II
Status	terminated
Initiated	2015-07-21
Published	2015-09-09
Last updated	2026-09-13 11:53 UTC
Company	Neuro Kinetics
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	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 900… 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

code_info

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 900…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2730-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.