BEUDAMED
    FDA Recall Terminated

    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.

    Recall: Z-1265-2009 · Initiated January 8, 2009

    Recall

    Recall Number
    Z-1265-2009
    Event Number
    51424
    Firm
    Imaging Sciences International, LLC
    FEI Number
    3021551875
    Product Code
    MUH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 8, 2009
    Posted
    May 22, 2009
    Terminated
    June 4, 2009
    Address
    1910 North Penn Rd, Hatfield, PA, 19440-1960

    Description

    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.

    Reason

    faulty calibration

    Action

    Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.

    Distribution

    Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.

    Quantity

    24 units