BEUDAMED
    FDA Recall Terminated

    Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.

    Recall: Z-0543-05 · Initiated January 17, 2005

    Recall

    Recall Number
    Z-0543-05
    Event Number
    31106
    Firm
    Biolase Technology Inc
    FEI Number
    2027755
    Product Code
    LYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 17, 2005
    Posted
    February 15, 2005
    Terminated
    August 17, 2005
    Address
    981 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.

    Reason

    Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.

    Action

    Water bottles will be replaced by trained Biolase representatives. During that visit, the representative will verify that the bottle pressure is set correctly and the existing bottle is replaced with a new bottle.

    Distribution

    Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan

    Quantity

    206 units