Device recall
Z-1795-2015: I-Portal NOTC and VNG; a device used to measure, record, or visually display the…
FDA device recall · Class II · Neuro Kinetics, Inc.
Key facts
| Recall number (Z-number) | Z-1795-2015 |
|---|---|
| Recall event | 71264 |
| Product | 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… |
| Product code | GWN |
| Recalling firm | Neuro Kinetics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2017 |
| 510(k) numbers | K083603 |
| FEI number | 2519945 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database