BEUDAMED
    FDA Recall Terminated

    KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.

    Recall: Z-0274-06 · Initiated October 20, 2005

    Recall

    Recall Number
    Z-0274-06
    Event Number
    33931
    Firm
    Eastman Kodak Co
    FEI Number
    1315356
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 20, 2005
    Posted
    December 8, 2005
    Terminated
    December 30, 2005
    Address
    343 State St, Rochester, NY, 14650

    Description

    KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.

    Reason

    Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.

    Action

    Letters dated 10/20/2005 were hand carried by Kodak Field Service Reps. Kodak Field Engineers inspected units and found the two defective units (both in China).

    Distribution

    DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.

    Quantity

    3