Z-0966-2014 Class II Terminated
FDA device recall Z-0966-2014 was initiated by Neuro Kinetics, Inc. on November 21, 2013 and is designated Class II. 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. The recall status is terminated (terminated July 20, 2015). Affected quantity: 148.
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