BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-1354-2023 · Initiated February 16, 2023

    Recall

    Recall Number
    Z-1354-2023
    Event Number
    91847
    Firm
    Solta Medical Inc
    FEI Number
    3004106598
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 16, 2023
    Posted
    April 7, 2023
    Address
    11720 N Creek Pkwy N, Ste 100, Bothell, WA, 98011-8244

    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.

    Reason

    A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

    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].

    Distribution

    U.S. Distribution to state of: MD

    Quantity

    1 unit