Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser Sy
Pending LLM rewrite. Source: FDA_DEVICE Z-1694-2026.
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 Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate
- 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-PLS
- UDI: 00821925044111
- Component Part: TFL-CPLU
- UDI: 00821925044586
- Serial #: MDUF220005
- MDUF220005
- MDUF220437
- MDUF220446
- MDUF190072
- MDUF200324
- MDUF210030
- MDUF210204
- MDUF210379
- MDUF220001
- MDUF220002
- MDUF220003
- MDUF220007
- MDUF220008
- MDUF220009
- MDUF220010
Distribution
Distributed nationwide across the United States.
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