FDAClass IIJune 24, 2015

I-Portal¿ NOTC and VNG recall

I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use…

Why was I-Portal¿ NOTC and VNG recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Neuro Kinetics, Inc.
Quantity
140
Distribution
Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
Recall date
June 24, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls