BEUDAMED
    FDA Recall Terminated

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    Recall: Z-2184-2012 · Initiated July 27, 2012

    Recall

    Recall Number
    Z-2184-2012
    Event Number
    62646
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    July 27, 2012
    Posted
    August 10, 2012
    Terminated
    January 13, 2015
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    Reason

    Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

    Action

    AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood. For questions customers were instructed tol call 401-604-2180. For questions regarding this recall call 864-421-1754.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada

    Quantity

    280