BEUDAMED
    FDA Recall Terminated

    Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display

    Recall: Z-0510-2007 · Initiated January 15, 2007

    Recall

    Recall Number
    Z-0510-2007
    Event Number
    37180
    Firm
    Candela Laser Corporation
    FEI Number
    1218402
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 15, 2007
    Posted
    February 15, 2007
    Terminated
    February 3, 2014
    Address
    530 Boston Post Rd, Wayland, MA, 01778-1833

    Description

    Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display

    Reason

    Internal component may overheat causing the possibility of risk of fire or smoke

    Action

    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.

    Distribution

    Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico

    Quantity

    474 laser systems total (all models)