Device recall
Z-0131-2008: American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part…
FDA device recall · Class II · AMS Innovative Center - San Jose
Key facts
| Recall number (Z-number) | Z-0131-2008 |
|---|---|
| Recall event | 38377 |
| Product | American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134 |
| Product code | GEX |
| Recalling firm | AMS Innovative Center - San Jose |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2010 |
| 510(k) numbers | K010284, K062719 |
| 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