Olympus SOLTIVE Premium Laser System Class II Recall - Power Supply Module Defect
Summary
FDA announced a Class II recall of Olympus SOLTIVE Premium SuperPulsed Laser Systems (model TFL-PLS) due to a potential defect in the 24V power supply module. The defect may cause the system to become inoperable and produce smoke or a burning smell. The recall affects units distributed US Nationwide and internationally to Canada, Chile, Europe, Singapore, Australia, and Hong Kong. The recall is ongoing.
What changed
Olympus initiated a Class II recall for SOLTIVE Premium SuperPulsed Laser Systems following complaint investigation that identified a defect in the 24V power supply module. The defect may render the system inoperable and produce smoke or a burning smell. \n\nHealthcare providers and facilities using these laser systems should identify whether their inventory contains affected units (model TFL-PLS containing TFL-CPLU), cease use pending correction, and contact Olympus Corporation of the Americas for remediation instructions. The recall affects devices distributed worldwide including US Nationwide.
What to do next
- Identify affected Olympus SOLTIVE Premium Laser System units
- Contact Olympus for repair or replacement information
- Remove affected devices from clinical use until corrected
Archived snapshot
Apr 14, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1694-2026 · 20260408 · Ongoing
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 electric...
Reason for Recall
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...
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
Source: openFDA Enforcement API
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