BEUDAMED
    FDA Enforcement Class II Terminated

    AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

    Recall: Z-2252-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2252-2012
    Event ID
    62796
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    August 9, 2012
    Classification Date
    August 22, 2012
    Termination Date
    December 8, 2015
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

    Reason

    Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).

    Code Info

    All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).

    Distribution

    USA Nationwide, Virgin Islands and Canada

    Quantity

    535