BEUDAMED
    FDA Recall Terminated

    PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.

    Recall: Z-1034-2019 · Initiated January 25, 2019

    Recall

    Recall Number
    Z-1034-2019
    Event Number
    82123
    Firm
    Agfa N.V. Septestraat 27 Mortsel Belgium
    FEI Number
    3001556265
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 25, 2019
    Terminated
    June 14, 2019

    Description

    PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.

    Reason

    Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities

    Action

    Agfa issued Medical Device Recall letter by email dated 1/28/19 stating the problem, action to be taken, health risk and to block the material to prevent distribution.

    Distribution

    US nationwide distribution in the state of OH.

    Quantity

    2029 boxes