Device recall
Z-0894-2013: Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator…
FDA device recall · Class II · Advanced Neuromodulation Systems Inc.
Key facts
| Recall number (Z-number) | Z-0894-2013 |
|---|---|
| Recall event | 61554 |
| Product | Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. |
| Product code | MHY |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2013 |
| 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