Device recall
Z-0117-2016: NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data…
FDA device recall · Class II · Natus Neurology Inc
Key facts
| Recall number (Z-number) | Z-0117-2016 |
|---|---|
| Recall event | 71991 |
| Product | NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity… |
| Product code | GWQ |
| Recalling firm | Natus Neurology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2016 |
| 510(k) numbers | K964280 |
| FEI number | 3010611950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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