Olympus Corporation of the Americas Recall 88229
Description: 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 gynecological surgery
Olympus Corporation of the Americas Recall 88229 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2294-2021 |
| Event ID | 88229 |
| Event Description | 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 gynecological surgery |
| Product Type | Devices |
| Distribution | US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore |
| Quantity | 408 units |
| Recall Reason | Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets |
| Device Classification | 20210825 |
| Device Code Info | Software Version 2.0 (all serial numbers) |
| Center Classification Date | 20210815 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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