Device recall
Z-2320-2017: NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System…
FDA device recall · Class II · Nexstim PLC
Key facts
| Recall number (Z-number) | Z-2320-2017 |
|---|---|
| Recall event | 77198 |
| Product | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus… |
| Product code | GWF |
| Recalling firm | Nexstim PLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K112881 |
| FEI number | 3007147067 |
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