SOLTIVE Laser System Recalled for Potential Thermal Incident Risk
Olympus is recalling 1,549 SOLTIVE surgical laser systems due to potential thermal incidents—including smoke, sparks, burning, or unsteady flames—caused by fiber fracturing during clinical use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm surgical device with potential for serious thermal injury including burns and fire. No hospitalizations or injuries have been reported, and the hazard is described as potential rather than confirmed, placing this at High severity per rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,549 SOLTIVE Premium SuperPulsed Laser Systems (models TFL-PLS and TFL-PLS-JA). These are powered surgical laser instruments used in ureteroscopy, percutaneous nephrolithotomy (PCNL), and other soft tissue applications.
The recall was issued due to the potential for thermal incidents during clinical use, including unexpected occurrences of smoke, sparks, burning, or unsteady flames. These incidents are caused by fracturing of the laser fiber.
The affected units were distributed worldwide, including in the United States and Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore. Healthcare providers using these systems should be aware of the potential thermal hazard during clinical use.
The recalled product
- Product
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and f
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Surgical Laser
- Hazard
- thermal-incident
- burn-injury
- fire-risk
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 (1)
- TFL-PLS-JA (Japan only)
Distribution
Distributed nationwide across the United States.
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