Device recall
Z-0545-06: Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems…
FDA device recall · Class II · Lumenis Inc.
Key facts
| Recall number (Z-number) | Z-0545-06 |
|---|---|
| Recall event | 34525 |
| Product | Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104 |
| Product code | GEX |
| Recalling firm | Lumenis Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2006 |
| 510(k) numbers | K913569 |
| FEI number | 2914019 |
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