Thermage CPT System unit improperly tested and calibrated during manufacturing
Solta Medical is recalling one Thermage CPT System unit that was potentially improperly tested and calibrated during manufacturing. The company is contacting the affected customer regarding corrective action.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is improper testing and calibration during manufacturing affecting a single unit, representing a potential but undemonstrated risk of harm.
Plain-English summary
Solta Medical, Inc. is recalling one Thermage CPT System unit (Model TG-2B, Serial Number 001933) distributed to Maryland. This unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
The Thermage CPT System is used for dermatologic and general surgical procedures, including non-invasive treatment of periorbital wrinkles and facial skin conditions. The system consists of an RF generator, cooling system, handpieces, and accessory components.
This manufacturing defect affects only one unit. Solta Medical is contacting the affected customer regarding inspection or corrective action. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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 u
- Manufacturer
- Solta Medical Inc
- Hazard
- improper-calibration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933
Distribution
Distributed in 1 state:
- MD
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