Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL
Pending LLM rewrite. Source: FDA_DEVICE Z-1695-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
The recalled product
- Product
- Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tis
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Laser System: TFL-SLS
- UDI: 00821925044135
- Component Part: TFL-CSLU
- UDI: 00821925044593
- Serial #: MDUF190114
- MDUF220073
- MDUF220331
- MDUF220353
- MDUF220354
- MDUF220356
- MDUF220411
- MDUF220412
- MDUF220413
- MDUF220414
- MDUF220427
- MDUF220451
- MDUF220453
- MDUF220454
- MDUF220455
- MDUF220456
Distribution
Distributed nationwide across the United States.
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