Device recall
Z-0581-2016: Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926…
FDA device recall · Class II · Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Key facts
| Recall number (Z-number) | Z-0581-2016 |
|---|---|
| Recall event | 72763 |
| Product | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks… |
| Product code | GWQ |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 3, 2016 |
| 510(k) numbers | K143440 |
| FEI number | 3002809369 |
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