Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical Recalled by Solta Medical Inc Due to A service unit was potentially improperly tested and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Solta Medical Inc directly.
Affected Products
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.
Quantity: 1 unit
Why Was This Recalled?
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Where Was This Sold?
This product was distributed to 1 state: MD
About Solta Medical Inc
Solta Medical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report