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.
FDA Recall Z-1354-2023 · Posted 2023-04-07
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Recalling FirmSolta Medical Inc
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2023-02-16
Product Quantity1 unit
Reason for Recall
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Firm 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].
Root Cause
Process control
Distribution Pattern
U.S. Distribution to state of: MD
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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