Device recall
Z-0556-06: Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers…
FDA device recall · Class II · Lumenis Inc.
Key facts
| Recall number (Z-number) | Z-0556-06 |
|---|---|
| Recall event | 34574 |
| Product | Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 |
| Product code | GEX |
| Recalling firm | Lumenis Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2006 |
| 510(k) numbers | K003614 |
| 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