Recall record at a glance
| Official record | Z-1354-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Solta Medical Inc. |
| Report date | Apr 19, 2023 |
| Recall initiation date | Feb 16, 2023 |
| Quantity | 1 unit |
| Location | Bothell, WA, United States |
Official product description
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.
Why the product was recalled
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Distribution information
U.S. Distribution to state of: MD
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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