BEUDAMED
    FDA Enforcement Class II Terminated

    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    Recall: Z-3047-2017 · Reported August 30, 2017

    Enforcement

    Recall Number
    Z-3047-2017
    Event ID
    77655
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Solta Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 30, 2017
    Initiation Date
    June 1, 2017
    Classification Date
    August 21, 2017
    Termination Date
    November 30, 2020
    Address
    11720 N Creek Pkwy N Ste 100, Bothell, WA, 98011-8244, United States

    Description

    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    Reason

    Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.

    Code Info

    Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.

    Distribution

    US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.

    Quantity

    4 units