Home / Recalls / Neuro Kinetics, Inc. / Z-0966-2014

Z-0966-2014 Class II Terminated

Recalled by Neuro Kinetics, Inc. — Pittsburgh, PA

Recall Details

Product Type
Devices
Report Date
February 19, 2014
Initiation Date
November 21, 2013
Termination Date
July 20, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
148

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.

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.

Distribution Pattern

Distributed USA (nationwide) and the country of Canada.

Code Information

Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1

Other recalls by Neuro Kinetics, Inc.

  • Z-2730-2015 Class II — Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a (July 21, 2015)
  • Z-1795-2015 Class II — I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display th (April 30, 2015)