Class 2 Device Recall Thermage CPT System TG2B

• Date Initiated by Firm: February 16, 2023
• Date Posted: April 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1354-2023
• Recall Event ID: 91847
• 510(K)Number: K173759
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• 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.
• Code Information: Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933
• Recalling Firm/ Manufacturer: Solta Medical Inc; 11720 N Creek Pkwy N Ste 100; Bothell WA 98011-8244
• For Additional Information Contact: Jody Johnson; 425-420-2186
• Manufacturer Reason for Recall: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
• FDA Determined 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: Jody.Johnson@solta.com.
• Quantity in Commerce: 1 unit
• Distribution: U.S. Distribution to state of: MD
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEI