Device recall
Z-2294-2021: Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-2294-2021 |
|---|---|
| Recall event | 88229 |
| Product | Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and… |
| Product code | GEX |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2024 |
| 510(k) numbers | K211401 |
| FEI number | 2429304 |
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