Device recall
Z-2281-2012: The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel…
FDA device recall · Class II · Advanced Neuromodulation Systems Inc.
Key facts
| Recall number (Z-number) | Z-2281-2012 |
|---|---|
| Recall event | 61171 |
| Product | The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of… |
| Product code | LGW |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2015 |
| PMA numbers | P010032, P010032S023 |
| FEI number | 1627487 |
At a glance
- None 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