BEUDAMED
    FDA Recall Terminated

    i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.

    Recall: Z-0543-2010 · Initiated October 30, 2009

    Recall

    Recall Number
    Z-0543-2010
    Event Number
    53771
    Firm
    Imaging Sciences International, LLC
    FEI Number
    3021551875
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 30, 2009
    Posted
    December 17, 2009
    Terminated
    September 30, 2010
    Address
    1910 North Penn Rd, Hatfield, PA, 19440-1960

    Description

    i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.

    Reason

    overhead carriage drops quickly

    Action

    Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.

    Distribution

    Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.

    Quantity

    98 units