Reported Apr 19, 2023 · Ongoing
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.…
Solta Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Solta Medical Inc · 11720 N Creek Pkwy N Ste 100 · Bothell, WA · 98011-8244
Is this the product you have?
- 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.
- Lot codes and dates
- Model NumberTG-2B
- UDI-DI Code00850608002124
- Serial Number001933
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
This product could cause temporary or reversible health problems — stop using it.
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