BEUDAMED
    FDA Recall Terminated

    eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray

    Recall: Z-0009-2015 · Initiated August 12, 2014

    Recall

    Recall Number
    Z-0009-2015
    Event Number
    69064
    Firm
    Gendex Corp
    FEI Number
    3009212242
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 12, 2014
    Posted
    October 2, 2014
    Terminated
    March 24, 2017
    Address
    2800 Crystal Dr, Hatfield, PA, 19440-1944

    Description

    eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray

    Reason

    Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.

    Action

    Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.

    Quantity

    651