Olympus recalls 408 SOLTIVE Premium Laser System units worldwide after a defect in the 24V power supply may render the system inoperable and cause smoke or a burning smell. The issue is contained within the internal console and would self-extinguish. Hospitals should stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions
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Product: Olympus SOLTIVE Premium Laser System, Model TFL-PLS, Component TFL-CPLU UDI (Laser system): 00821925044111 UDI (Component): 00821925044586 Serial numbers included: MDUF220005, MDUF220437, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008 Quantity: 408 units Distribution: Worldwide, including US nationwide, Canada, Chile, Europe, Singapore, Australia, and Hong Kong Sold at: Unknown/Worldwide distribution
A defect in the 24V power supply module may cause the SOLTIVE laser system to become inoperable. Smoke or a burning smell may occur. The issue is designed to be contained within the internal laser console enclosure and would be self-extinguishing.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. 4. Do not operate the device until cleared. 5. Maintain records of the recall communication and any service actions.
Recall notices and instructions are available through the FDA enforcement page. For manufacturer guidance, contact Olympus Corporation of the Americas. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1694-2026 Hours: Not specified
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