Olympus Corporation of the Americas: Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FB

Hazard

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Details from the source

Reason for recall: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents. Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG. Quantity: 551,154 units (417859 US, 133710 OUS) Lot/code info: Lot Code: All lot numbers for the following products: TFL-FBX150BS UDI: 00821925043923; TFL-FBX200BS UDI: 00821925043985; TFL-FBX150S UDI: 00821925043886; TFL-FBX200S UDI: 00821925043947; TFL-FBX365S UDI: 00821925044005; TFL-FBX550S UDI: 00821925044043; TFL-FBX940S UDI: 00821925044081; TFL-FBX150BS-JA (Japan Only); TFL-FBX550S-JA (Japan Only); TFL-FBX940S-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150S-JA (Japan Only); TFL-FBX200S-JA (Japan Only); TFL-FBX365S-JA (Japan Only);

UPC codes

00821925043923, 00821925043985, 00821925043886, 00821925043947, 00821925044005, 00821925044043, 00821925044081

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.