Olympus recalled 32 SOLTIVE Pro SuperPulsed Laser System units distributed worldwide after a defect in the 24V power supply may render the device inoperable. The defect can cause smoke or a burning smell, but the issue is contained within the laser console enclosure and self-extinguishing. Stop using the device and follow the manufacturer’s 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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Model/Catalog Number: TFL-SLS containing TFL-CSLU. Laser System: SOLTIVE Pro. UDI: 00821925044135 (TFL-SLS) and UDI: 00821925044593 (TFL-CSLU). Serial numbers include MDUF190114 and multiple codes MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456. Quantity recalled: 32 units. Distribution: Worldwide including US nationwide and markets in Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
A defect in the 24V power supply module may cause the SOLTIVE Pro to become inoperable. The defect can produce smoke or a burning smell. Any fire is contained within the internal laser console enclosure and self-extinguishing.
No injuries or incidents have been reported.
1. Stop using the product immediately. 2. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. 3. Follow the manufacturer’s recall instructions for repair, replacement, or refund. 4. Have your device’s model numbers, serial numbers, and UDI codes ready for verification. 5. For refunds or replacements, refer to the recall notice and FDA page for instructions: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1695-2026.
Recall notice and details are accessible via the FDA enforcement page linked above. Direct phone numbers or hours are not provided in the data provided.
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