Device recall
Z-2165-2010: SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp…
FDA device recall · Class II · Natus Medical Inc
Key facts
| Recall number (Z-number) | Z-2165-2010 |
|---|---|
| Recall event | 56055 |
| Product | SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154 |
| Product code | GWJ |
| Recalling firm | Natus Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2011 |
| 510(k) numbers | K952080 |
| FEI number | 1419887 |
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