Drug recall
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for…
FDA recall event 88229 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 88229 |
|---|---|
| Recall numbers | Z-2294-2021 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets |
| Initiation date | Jun 30, 2021 |
| Report date | Aug 25, 2021 |
| Termination date | Jan 26, 2024 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: