BEUDAMED
    FDA Recall Terminated

    NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.

    Recall: Z-2137-2011 · Initiated March 4, 2011

    Recall

    Recall Number
    Z-2137-2011
    Event Number
    58166
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2011
    Posted
    May 4, 2011
    Terminated
    March 27, 2012
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.

    Reason

    When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.

    Action

    AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815.

    Distribution

    Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada

    Quantity

    775 units