Device 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.
Z-1354-2023
Product summary
- Event
- Event 91847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1354-2023
Official wording
Reason: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Code information: Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933
Distribution pattern: U.S. Distribution to state of: MD
Derived failure modes
-
Unknown
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.