Z-1354-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- February 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.
Reason for Recall
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Distribution Pattern
U.S. Distribution to state of: MD
Code Information
Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933