Device recall
Z-0028-2007: Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for…
FDA device recall · Class II · Lumenis Inc.
Key facts
| Recall number (Z-number) | Z-0028-2007 |
|---|---|
| Recall event | 36188 |
| Product | Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA |
| Product code | GEX |
| Recalling firm | Lumenis Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2007 |
| 510(k) numbers | K011703 |
| 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