Z-1923-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,675 units (190 US, 2485 OUS)
Product Description
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, 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); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.
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 Pattern
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Code Information
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);