Device recall
Z-2191-2013: Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053…
FDA device recall · Class II · Lumenis, Inc.
Key facts
| Recall number (Z-number) | Z-2191-2013 |
|---|---|
| Recall event | 66133 |
| Product | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. |
| Product code | GEX |
| Recalling firm | Lumenis, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2013 |
| 510(k) numbers | K111213 |
| FEI number | 1720381 |
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