BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX RIS QDOC 5.8

    Recall: Z-0919-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0919-2014
    Event ID
    67275
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 12, 2014
    Initiation Date
    January 8, 2014
    Classification Date
    February 3, 2014
    Termination Date
    February 28, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    IMPAX RIS QDOC 5.8

    Reason

    Patient name displayed (printed) on the Patient Report was the wrong patient name.

    Code Info

    Software IMPAX RIS 58 and higher

    Distribution

    CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada

    Quantity

    14