BEUDAMED
    FDA Recall Terminated

    KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm

    Recall: Z-0817-05 · Initiated April 8, 2005

    Recall

    Recall Number
    Z-0817-05
    Event Number
    31494
    Firm
    Eastman Kodak Co
    FEI Number
    1315356
    Product Code
    IXJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 8, 2005
    Posted
    May 11, 2005
    Terminated
    December 19, 2005
    Address
    343 State St, Rochester, NY, 14650

    Description

    KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm

    Reason

    Screens may be affected with image artifacts

    Action

    Letters mailed 4/8/2005. Customers informed of the problem and advised that Kodak representatives will exchange the recalled screens for new screens.

    Distribution

    There are 263 U.S. customers; 22 Canadian customers; 74 Japanese customers; 213 Greater Asian Region customers; 19 Latin American customers; 306 Europe/Africa/ Middle East customers.

    Quantity

    Approximately 6,900 screens