Device recall
Z-0966-2014: Normative Data Template CD for use with the I-Portal devices. Used to measure…
FDA device recall · Class II · Neuro Kinetics, Inc.
Key facts
| Recall number (Z-number) | Z-0966-2014 |
|---|---|
| Recall event | 66995 |
| Product | 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. |
| Product code | GWN |
| Recalling firm | Neuro Kinetics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2015 |
| 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