BEUDAMED
    FDA Recall Terminated

    Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only.

    Recall: Z-0150-04 · Initiated October 9, 2003

    Recall

    Recall Number
    Z-0150-04
    Event Number
    27488
    Firm
    Konica Medical Imaging, Inc.
    FEI Number
    2241281
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 9, 2003
    Posted
    July 20, 2004
    Terminated
    July 29, 2004
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only.

    Reason

    Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.

    Action

    Recall letter sent out to direct accounts on 10/9/2003. The consignees are to review boxes and cases of emulsion film and contact the firm for a return aurthorization number.

    Distribution

    The firm distributed the duplicating firm to 960 imaging locations, clinics, and hospitals nationwide. There are 5 VA medical centers located in VA, RI, WI, NH, and TN.

    Quantity

    4383