Thermage recallZ-1354-2023 · Solta Medical Inc · initiated Feb 16, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Solta Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
FDA root cause category: Process control
What the company is doing
On 02/16/2023, the firm contacted customer via telephone e and then coordinate shipping out a loaner device as well as getting the unit (s/n: 001933) back for retest and possible recalibration. Documentation for the recall will be mailed with the loaner system to the customer. If you have any questions, contact Senior Director, Global Product Support at 425-420-2352 or email: [email protected].
Recall details
- Recall number
- Z-1354-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 16, 2023
- Posted by the FDA
- Apr 7, 2023
- Recalling firm
- Solta Medical Inc
- Quantity
- 1 unit
- Product code
- GEI
- FDA submissions
- K173759
- Distribution
- U.S. Distribution to state of: MD
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.
Code information (models, lots, serial numbers)
Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Thermage TG-2BSolta Medical · Massager, Therapeutic, Electric1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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