BEUDAMED
    FDA Recall 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 · Initiated August 9, 2012

    Recall

    Recall Number
    Z-2252-2012
    Event Number
    62796
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 9, 2012
    Posted
    August 22, 2012
    Terminated
    December 8, 2015
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    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).

    Action

    On 8/9/2012 AGFA Healthcare issued an "URGENT FIELD SAFETY NOTICE" letter to consignees. This letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was also required from the consignees

    Distribution

    USA Nationwide, Virgin Islands and Canada

    Quantity

    535