Device recall
Z-0025-2013: The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable…
FDA device recall · Class II · Advanced Neuromodulation Systems Inc.
Key facts
| Recall number (Z-number) | Z-0025-2013 |
|---|---|
| Recall event | 63154 |
| Product | The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to… |
| Product code | LGW |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2014 |
| PMA numbers | P010032 |
| 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