BEUDAMED
    FDA Enforcement Class II Terminated

    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System

    Recall: Z-0169-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0169-2015
    Event ID
    69463
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cynosure, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    October 9, 2014
    Classification Date
    November 4, 2014
    Termination Date
    March 26, 2015
    Address
    5 Carlisle Rd, N/A, Westford, MA, 01886, United States

    Description

    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System

    Reason

    If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock

    Code Info

    All Serial numbers

    Distribution

    Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.

    Quantity

    322 units