BEUDAMED
    FDA Enforcement Class III 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 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1034-2019
    Event ID
    82123
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Agfa N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 27, 2019
    Initiation Date
    January 25, 2019
    Classification Date
    March 21, 2019
    Termination Date
    June 14, 2019
    Address
    Septestraat 27, N/A, Mortsel, N/A, N/A, Belgium

    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

    Code Info

    REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.

    Distribution

    US nationwide distribution in the state of OH.

    Quantity

    2029 boxes