Olympus Corporation of the Americas: Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R,

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: 2,675 units (190 US, 2485 OUS) Lot/code info: Lot Code: All lot numbers for the following models: Model UDI: 5 Pack / 1 Piece: TFL-FBX150R UDI: 00821925043893 / 00821925043909 TFL-FBX200R UDI: 00821925043954 / 00821925043961 TFL-FBX365R UDI: 00821925044012 / 00821925044029 TFL-FBX550R UDI: 00821925044050 / 00821925044067 TFL-FBX940R UDI: 00821925044104 / 00821925044098 TFL-FBX940R-JA (Japan Only); TFL-FBX365R-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150R-JA (Japan Only); TFL-FBX200R-JA (Japan Only); TFL-FBX550R-JA (Japan Only);

UPC codes

00821925043893, 00821925043909, 00821925043954, 00821925043961, 00821925044012, 00821925044029, 00821925044050, 00821925044067, 00821925044104, 00821925044098

Source

Official record: FDA (Device enforcement) ↗

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