BEUDAMED
    FDA Recall Terminated

    Picasso/Picasso Lite lasers Intended use: Dentistry.

    Recall: Z-2349-2010 · Initiated April 15, 2010

    Recall

    Recall Number
    Z-2349-2010
    Event Number
    56330
    Firm
    AMD Lasers, LLC
    FEI Number
    3003258642
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 15, 2010
    Posted
    September 10, 2010
    Terminated
    April 21, 2011
    Address
    7405 Westfield Blvd, Indianapolis, IN, 46240

    Description

    Picasso/Picasso Lite lasers Intended use: Dentistry.

    Reason

    Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the Picasso/Picasso Lite lasers could be removed with force while the key was in the ON position.

    Action

    Letters, dated April 30, 2010, addressed to Dental Professionals were sent identifying the affected product and reason for the recall. The letter asked customers to check their units and, if applicable, AMD Lasers would replace the key assembly on their lasers. The service would be provided free of charge including round trip shipping charges to the corporate office. Customers are to call to schedule the service and obtain a RMA number and shipping instructions. Questions should be directed to 1-866-999-2635 or [email protected].

    Distribution

    Worldwide Distribution

    Quantity

    3,000 units