BEUDAMED
    FDA Recall Terminated

    Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne

    Recall: Z-0692-2013 · Initiated November 7, 2012

    Recall

    Recall Number
    Z-0692-2013
    Event Number
    64039
    Firm
    Quanta System, S.p.A. Via IV Novembre, 116 Solbiate Olona (VA) Italy
    FEI Number
    3004378299
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    November 7, 2012
    Posted
    January 17, 2013
    Terminated
    January 23, 2013

    Description

    Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne

    Reason

    Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.

    Action

    Quanta System sent a letter dated November 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following: quarantine and destroy all promotional literature printed from the manufacturer, website or obtained from the manufacturer. Provide any promotional literature independently produced by the initial importer or distributor containing information about Quanta System products. Provide URL of initial importers or distributors website if information about Quanta System products is contained therein. Provide a written certification that all actions have been taken. Quanta System has or will: review all promotional materials and website information provided by initial importers and distributors; advise initial importers and distributors of any actions that need to be taken to change promotional materials and/or website information. For questions regarding this recall call 303-223-4336.

    Distribution

    Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.

    Quantity

    12 units