Z-2730-2015Class II

Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in...

Name: Z-2730-2015 Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in...
Creator: Neuro Kinetics, Inc.
Published: 2015-07-21
License: https://open.fda.gov/license/

Spryson America Inc / initiated 2015-07-21 / Terminated / root cause: labeling and UDI

FDA source

Neuro Kinetics, Inc. began a recall of 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... on 2015-07-21. FDA classified it as Class II and gives the reason as "The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2730-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-21
Posted: 2015-09-03
Terminated: 2016-09-27
Recalling firm: Spryson America Inc
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.
Product code: GWN Nystagmograph
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: Neuro Kinetics sent notification letters to end users on/about July 24, 2015, to alert them to the reason for recall and inform them of the corrective action planned by Neurokinetics. Action to be taken by you the Customer/User: If you have already initiated OVAR research (an IRB approved study with non-significant risk designation is ongoing), please reply to this email and include a copy of the IRB approval letter or the IRB approval information (e.g., investigators name, IRB name, IRB location, and study reference number). In return, NKI will mail you a field correction package with the necessary and appropriate Investigational Device labeling. If you have not initiated OVAR research (an IRB approved study is not ongoing), please discontinue use of the OVAR test and reply to this email to confirm that you are not using the OVAR test as part of an IRB approved study. In return, NKI will mail you a field correction package to disable the OVAR test functionality, which can be restored at the time you have an IRB approved study. Disabling the OVAR research test will have no effects on the functionality of the clinical tests included with your NOTC system. There will be no perceivable changes to the system outside of not being able to run the OVAR test. For questions regarding this recall call 412-963-6649.
Quantity in commerce: 45
Distribution: Worldwide Distribution - US (nationwide)
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2730-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2730-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-03

Product code GWN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)