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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description 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.
Recall Number Z-0966-2014
Classification Class II
Code Info Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
Product Distributed Qty 148
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.

Event Detail

Event Id 66995
Product Type Devices
Status Ongoing
Recalling Firm Neuro Kinetics, Inc.
City Pittsburgh
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-21
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Distributed USA (nationwide) and the country of Canada.