BEUDAMED
    FDA Recall Terminated

    Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA

    Recall: Z-1248-2011 · Initiated December 17, 2010

    Recall

    Recall Number
    Z-1248-2011
    Event Number
    57485
    Firm
    Gendex Dental Systems
    FEI Number
    3004115000
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 17, 2010
    Posted
    February 15, 2011
    Terminated
    February 15, 2011
    Address
    901 W Oakton St, Des Plaines, IL, 60018-1843

    Description

    Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA

    Reason

    The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.

    Action

    Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.

    Distribution

    California

    Quantity

    5 units