Device recall
Z-0946-2013: Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers: 515-015400…
FDA device recall · Class II · Natus Neurology Incorporated
Key facts
| Recall number (Z-number) | Z-0946-2013 |
|---|---|
| Recall event | 64479 |
| Product | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit… |
| Product code | GWL |
| Recalling firm | Natus Neurology Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2014 |
| 510(k) numbers | K103140 |
| FEI number | 3010611950 |
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