BEUDAMED
    FDA Enforcement Class II Terminated

    Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.

    Recall: Z-0691-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0691-2013
    Event ID
    64039
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quanta System, S.p.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2013
    Initiation Date
    November 7, 2012
    Classification Date
    January 17, 2013
    Termination Date
    January 23, 2013
    Address
    Via IV Novembre, 116, N/A, Solbiate Olona (VA), N/A, N/A, Italy

    Description

    Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.

    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.

    Code Info

    All codes and devices are applicable.

    Distribution

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

    Quantity

    75 units