Device recall
Z-2730-2015: Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a…
FDA device recall · Class II · Neuro Kinetics, Inc.
Key facts
| Recall number (Z-number) | Z-2730-2015 |
|---|---|
| Recall event | 71832 |
| Product | Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until… |
| Product code | GWN |
| Recalling firm | Neuro Kinetics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2016 |
| 510(k) numbers | K083603, K143607 |
| 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