BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

    Recall: Z-0035-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0035-2014
    Event ID
    66424
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    September 19, 2013
    Classification Date
    October 21, 2013
    Termination Date
    October 24, 2013
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

    Reason

    System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

    Code Info

    N/A

    Distribution

    Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.

    Quantity

    4