BEUDAMED
    FDA Recall Terminated

    Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color

    Recall: Z-0291-04 · Initiated November 25, 2003

    Recall

    Recall Number
    Z-0291-04
    Event Number
    27954
    Firm
    Candela Laser Corporation
    FEI Number
    1218402
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2003
    Posted
    January 1, 2004
    Terminated
    December 6, 2006
    Address
    530 Boston Post Rd, Wayland, MA, 01778-1833

    Description

    Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color

    Reason

    Laser may pulse and not dispense cryogen resulting in patient injury

    Action

    Candela notified direct customers and distributors by letter dated 11125/03 and issued Certified Mail. Accounts are requested to perform two tests on the unit to determine if the unit has the problem. If a unit fails, Candela's Field Service will make the repair. Distributors are requested to notify their customers.

    Distribution

    Nationwide Foreign: Canada,Thailand, Germany, Spain , Japan, Italy, Greece, Saudi Arabia, UK, France, Switzerland, Mexico, Ukraine, Kuwait, Netherlands.

    Quantity

    506 units