Device recall
Z-1441-2020: SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085…
FDA device recall · Class III · Advanced Bionics, LLC
Key facts
| Recall number (Z-number) | Z-1441-2020 |
|---|---|
| Recall event | 84800 |
| Product | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics… |
| Product code | MCM |
| Recalling firm | Advanced Bionics, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 27, 2022 |
| PMA numbers | P960058 |
| FEI number | 1000220815 |
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