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Vestibular First

Vestibular First, LLC · Model Insight Infrared Video Goggles Pro+ · UDI-DI 00860002280745

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510(k) clearances

Adverse events

Recalls

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Description

The Insight Infrared Video Goggles Pro+ are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.

Recalls

Date	Firm	Reason
2015-07-21	Neuro Kinetics, Inc.	The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
2015-04-30	Neuro Kinetics, Inc.	complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
2014-07-09	Integra LifeSciences Corp.	Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
2013-11-21	Neuro Kinetics, Inc.	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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.