Z-0966-2014Class II

Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display...

Name: Z-0966-2014 Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display...
Creator: Neuro Kinetics, Inc.
Published: 2013-11-21
License: https://open.fda.gov/license/

Spryson America Inc / initiated 2013-11-21 / Terminated

FDA source

Neuro Kinetics, Inc. began a recall of 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 on 2013-11-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0966-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2014-02-10
Terminated: 2015-07-20
Recalling firm: Spryson America Inc
Product: 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.
Product code: GWN Nystagmograph
Reason for recall: 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.
FDA root cause: No Marketing Application
Action: A recall notification letter, dated November 2013, was sent to Users. A follow up letter regarding scheduling removal of the software is planned for December 2013.
Quantity in commerce: 148
Distribution: Distributed USA (nationwide) and the country of Canada.
Product codes and lots: Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0966-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0966-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

Product code GWN

K083603Class III-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (Vng), I-Portal Neuro OtolNeuro Kinetics / cleared 2009-08-06

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)