Device recall
Z-1669-2016: Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne…
FDA device recall · Class II · Lumenis Ltd
Key facts
| Recall number (Z-number) | Z-1669-2016 |
|---|---|
| Recall event | 73765 |
| Product | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). |
| Product code | GEX |
| Recalling firm | Lumenis Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2016 |
| 510(k) numbers | K142860 |
| FEI number | 3004135191 |
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