Device recall
Z-0750-2013: Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the…
FDA device recall · Class II · Envoy Medical Corporation
Key facts
| Recall number (Z-number) | Z-0750-2013 |
|---|---|
| Recall event | 63875 |
| Product | Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. |
| Product code | OAF |
| Recalling firm | Envoy Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2013 |
| PMA numbers | P090018 |
| FEI number | 3004007782 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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