Device recall
Z-0397-2007: Portrait PSR3 System, an electro-surgical device used in dermatological…
FDA device recall · Class II · Rhytec Inc.
Key facts
| Recall number (Z-number) | Z-0397-2007 |
|---|---|
| Recall event | 37143 |
| Product | Portrait PSR3 System, an electro-surgical device used in dermatological applications |
| Product code | GEI |
| Recalling firm | Rhytec Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2016 |
| 510(k) numbers | K060948 |
| FEI number | 3004948955 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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