BEUDAMED
    FDA Recall Terminated

    Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300

    Recall: Z-0842-06 · Initiated January 17, 2006

    Recall

    Recall Number
    Z-0842-06
    Event Number
    35221
    Firm
    Candela Laser Corporation
    FEI Number
    1218402
    Product Code
    GXE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 17, 2006
    Posted
    May 4, 2006
    Terminated
    May 4, 2006
    Address
    530 Boston Post Rd, Wayland, MA, 01778-1833

    Description

    Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300

    Reason

    Handle fires even when the finger is off the switch

    Action

    Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system.

    Distribution

    Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland

    Quantity

    59 units