Exact FDA event identifier

Event 71264

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: April 30, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Neuro Kinetics, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1795-2015

Recall number: Z-1795-2015
Initiated: April 30, 2015
Classification: Class II
Status: Terminated
Recalling firm: Neuro Kinetics, Inc.
Quantity: 140

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.