BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0169-2015 · Initiated October 9, 2014

    Recall

    Recall Number
    Z-0169-2015
    Event Number
    69463
    Firm
    Cynosure, Inc.
    FEI Number
    1000120578
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 9, 2014
    Posted
    November 4, 2014
    Terminated
    March 26, 2015
    Address
    5 Carlisle Rd, Westford, MA, 01886

    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

    Action

    Cynosure sent an Urgent Medical Device Recall Notification dated October 9, 2014, to all affected customers. They were also notified by phone. The letter identified the product the problem and the action needed to be taken by the customer. There are two methods for returning the Elite XPL handpieces. If the handpiece is NOT currently connected to the laser console, the customer will be asked to return it to the Cynosure office. If the handpiece is not connected there is no risk. If the handpiece is currently connected to the laser console, the customer is instructed to immediately discontinue use of the laser system and to turn off the system immediately. They are also being instructed to leave the handpiece attached to the console and to not touch it. A Cynosure Field service engineer will then come to the office and remove the handpiece and return it to the Cynosure factory. In addition, the Cynosure Field Service engineer will install an interlock into the connector receptacle on the laser console. This interlock plug is an existing component that is used on systems that do not have an IPL handpiece in place. If your XPL pulsed light handpiece is not attached to the laser system please call Cynosure customer service (1-877-222-6822) to arrange for the handpiece to be returned and repaired.

    Distribution

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

    Quantity

    322 units