RecallRadar

FDA Device recall Z-1795-2015

I-Portal¿ NOTC and VNG

On 2015-06-24 the FDA classified a Class II recall of I-Portal¿ NOTC and VNG by Neuro Kinetics, citing complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1795-2015
ClassificationClass II
Statusterminated
Initiated2015-04-30
Published2015-06-24
Last updated2026-09-13 11:53 UTC
CompanyNeuro Kinetics
DistributionUS

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.

Reason

complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

Identifiers

code_infoModel Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3

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-1795-2015%22

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