Device recall
Z-0834-2011: GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight…
FDA device recall · Class II · AMS Innovative Center - San Jose
Key facts
| Recall number (Z-number) | Z-0834-2011 |
|---|---|
| Recall event | 56763 |
| Product | GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue. |
| Product code | GEX |
| Recalling firm | AMS Innovative Center - San Jose |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 3, 2011 |
| 510(k) numbers | K092735, K100746 |
| FEI number | 2937094 |
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