Device recall
Z-0956-2009: HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC…
FDA device recall · Class II · Advanced Bionics LLC
Key facts
| Recall number (Z-number) | Z-0956-2009 |
|---|---|
| Recall event | 50204 |
| Product | HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy… |
| Product code | MCM |
| Recalling firm | Advanced Bionics LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| PMA numbers | P960058 |
| FEI number | 3006556115 |
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