Z-1795-2015Class II

I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements...

Name: Z-1795-2015 I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements...
Creator: Neuro Kinetics, Inc.
Published: 2015-04-30
License: https://open.fda.gov/license/

Spryson America Inc / initiated 2015-04-30 / Terminated / root cause: software

FDA source

Neuro Kinetics, Inc. began a recall of I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a... on 2015-04-30. FDA classified it as Class II and gives the reason as "complaints of system malfunction and unintended, sudden movement at start up. No injuries reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1795-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-30
Posted: 2015-06-12
Terminated: 2017-04-17
Recalling firm: Spryson America Inc
Product: I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Product code: GWN Nystagmograph
Reason for recall: complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
Root cause tag: software
FDA root cause: Software design
Action: Neuro Kinetics sent a Field Correction Advisory letter dated April 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected product were instructed to contact Customer Service if a malfunction is encountered and not to use the device until it has been assessed and corrected by Nuerokinetics. Customers with questions should call 412-963-6649.
Quantity in commerce: 140
Distribution: Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
Product codes and lots: Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1795-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1795-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-12

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)