Device recall
Z-1404-2010: Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
FDA device recall · Class II · Novasys Medical Inc
Key facts
| Recall number (Z-number) | Z-1404-2010 |
|---|---|
| Recall event | 53031 |
| Product | Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA |
| Product code | NVJ |
| Recalling firm | Novasys Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2011 |
| 510(k) numbers | K042132 |
| FEI number | 3003647794 |
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