Device recall
Z-1229-2011: AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is…
FDA device recall · Class II · AMS Innovative Center - San Jose
Key facts
| Recall number (Z-number) | Z-1229-2011 |
|---|---|
| Recall event | 56058 |
| Product | AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, San Jose, CA The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of… |
| Product code | GEX |
| Recalling firm | AMS Innovative Center - San Jose |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2011 |
| 510(k) numbers | K010284 |
| 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