BEUDAMED
    FDA Recall Terminated

    Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.

    Recall: Z-0816-2007 · Initiated April 28, 2006

    Recall

    Recall Number
    Z-0816-2007
    Event Number
    37838
    Firm
    Instrumentarium Dental, Inc.
    FEI Number
    3005383085
    Product Code
    EDH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2006
    Posted
    May 18, 2007
    Terminated
    February 24, 2008
    Address
    300 West Edgerton Avenue, Milwaukee, WI, 53207

    Description

    Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.

    Reason

    There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.

    Action

    A recall letter, dated 04/28/2006, was sent to affected customers . The letter describes the issue, and requests that no patient operation is permitted until the unit is checked by authorized service technician. If the service technician noted wear of the screw, the assembly was replaced.

    Distribution

    Worldwide, including USA, Canada, Bermuda, and Colombia.

    Quantity

    9