Device recall
Z-0291-04: Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820…
FDA device recall · Class II · Candela Laser Corporation
Key facts
| Recall number (Z-number) | Z-0291-04 |
|---|---|
| Recall event | 27954 |
| Product | Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color |
| Product code | GEX |
| Recalling firm | Candela Laser Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2006 |
| 510(k) numbers | K013825, K022884, K030834, K030846 |
| FEI number | 1218402 |
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