Device recall
Z-3091-2011: Software version 3.3 for Rapid Programmer devices, Model 3832. Software version…
FDA device recall · Class II · Advanced Neuromodulation Systems
Key facts
| Recall number (Z-number) | Z-3091-2011 |
|---|---|
| Recall event | 57806 |
| Product | Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family. |
| Product code | LGW |
| Recalling firm | Advanced Neuromodulation Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2012 |
| 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