Device recall
Z-0700-2013: GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance…
FDA device recall · Class II · AMS Innovative Center - San Jose
Key facts
| Recall number (Z-number) | Z-0700-2013 |
|---|---|
| Recall event | 63972 |
| Product | GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the… |
| Product code | GEX |
| Recalling firm | AMS Innovative Center - San Jose |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2014 |
| 510(k) numbers | K062719, K092735 |
| 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