Device recall
Z-1918-2015: StoneLight 30 Laser System (NS3000). For use in surgical procedures using open…
FDA device recall · Class II · New Star Lasers, Inc.
Key facts
| Recall number (Z-number) | Z-1918-2015 |
|---|---|
| Recall event | 71346 |
| Product | StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. |
| Product code | GEX |
| Recalling firm | New Star Lasers, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2016 |
| 510(k) numbers | K142286 |
| FEI number | 1000307100 |
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