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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The SOLTIVE Premium Laser System is a high-power surgical laser platform used for soft tissue ablation with hemostasis. It is designed for precise tissue vaporization while limiting char and necrosis. The recall involves a power-supply defect that could interrupt operation during use.
A defect in the 24V power supply module may cause the device to stop functioning. Smoke or a burning smell may occur, but the issue is contained within the console enclosure and self-extinguishing.
This recall is not described as part of a broader industry pattern.
The recall could disrupt procedures and require immediate device shutdowns. There are no reported injuries yet. Hospitals may need to substitute equipment and await a replacement or service action.
Serial numbers and UDI are printed on the device label. UDI for laser system is 00821925044111. Component UDI is 00821925044586.
Recall actions and service or replacement will be coordinated by Olympus. Affected units should remain non-operational until cleared by the company.
Keep the recall notice, serial numbers, device label, and all correspondence with Olympus. Save incident reports and service logs for records.
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
No injuries or incidents have been reported.
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