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Solta Medical Inc recalls thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.
Recalled April 19, 2023 · FDA recall Z-1354-2023 · Solta Medical
Hazard
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. · FDA Class II
Units
1 unit
Sold at
U.S. Distribution to state of: MD
Description
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Product
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.
Manufacturer(s)
Solta Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →