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Terminated

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.

FDA Recall Z-0966-2014 · Posted 2014-02-10

Recalling FirmNeuro Kinetics, Inc.
Recall StatusTerminated
Product CodeGWN
Date Initiated2013-11-21
Date Terminated2015-07-20
Product Quantity148

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.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

Distributed USA (nationwide) and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083603I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOLNeuro Kinetics · 2009-08-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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