Recall Z-1795-2015 ยท GWN Nystagmograph
Neuro Kinetics, Inc.
I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
| Date | Jun 12, 2015 (initiated Apr 30, 2015) |
| Status | Terminated |
| Reason | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. |
| Root cause | Software design |
| Action | Neuro Kinetics sent a Field Correction Advisory letter dated April 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected product were instructed to contact Customer Service if a malfunction is encountered and not to use the device until it has been assessed and corrected by Nuerokinetics. Customers with questions should call 412-963-6649. |
| Quantity | 140 |
| Distribution | Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico. |
| 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 |