Z-1354-2023Class II

thermage THERMAGE CPT SYSTEM REF TG-2B * Solta Medical, Inc. thermage RF GENERATOR REF TG-2B * Solta...

Name: Z-1354-2023 thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta...
Creator: Solta Medical Inc
Published: 2023-02-16
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2023-02-16 / Open, Classified / root cause: manufacturing process

FDA source

Solta Medical Inc began a recall of thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical... on 2023-02-16. FDA classified it as Class II and gives the reason as "A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1354-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-16
Posted: 2023-04-07
Recalling firm: Solta Medical, Inc.
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 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 1 unit
Distribution: U.S. Distribution to state of: MD
Product codes and lots: Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1354-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1354-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-07

Product code GEI

K173759Class IIThermage CPT System and AccessoriesSolta Medical / cleared 2018-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)