FDA Device recall Z-1385-2024
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) by Olympus, citing A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1385-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-29 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | n/a |
Product
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Reason
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Identifiers
| code_info | Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2024%22
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