FDA Device recall Z-2294-2021
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection,…
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection,… by Olympus, citing thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2294-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-30 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
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 gynecological surgery
Reason
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Identifiers
| code_info | Software Version 2.0 (all serial numbers) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2294-2021%22
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