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Vestibular First, LLC · Model Insight Infrared Video Goggles Pro · UDI-DI 00860002280738

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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.