Device recall
Z-1180-2012: SoundBite Hearing System; Microphone Tube Size 1. For use in patients with…
FDA device recall · Class III · Sonitus Medical Inc.
Key facts
| Recall number (Z-number) | Z-1180-2012 |
|---|---|
| Recall event | 61114 |
| Product | SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than… |
| Product code | LXB |
| Recalling firm | Sonitus Medical Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| 510(k) numbers | K110831 |
| FEI number | 3009200826 |
At a glance
- 1–9 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