Recall Z-0966-2014 ยท GWN Nystagmograph
Neuro Kinetics, Inc.
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.
| Date | Feb 10, 2014 (initiated Nov 21, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | A recall notification letter, dated November 2013, was sent to Users. A follow up letter regarding scheduling removal of the software is planned for December 2013. |
| Quantity | 148 |
| Distribution | Distributed USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL Neuro Kinetics, Aug 6, 2009 |