BEUDAMED
    FDA Recall Terminated

    Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI

    Recall: Z-1349-2008 · Initiated February 22, 2008

    Recall

    Recall Number
    Z-1349-2008
    Event Number
    46889
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 22, 2008
    Posted
    March 31, 2008
    Terminated
    July 27, 2010
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI

    Reason

    Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.

    Action

    All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.

    Distribution

    Nationwide to five hospitals in DC, NY, OH, TN, and VA.

    Quantity

    5 units