BEUDAMED
    FDA Recall Terminated

    Easy Diagnost Eleva Universal Fluoroscopic applications

    Recall: Z-0431-2014 · Initiated October 30, 2013

    Recall

    Recall Number
    Z-0431-2014
    Event Number
    66705
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 30, 2013
    Posted
    December 2, 2013
    Terminated
    January 9, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Easy Diagnost Eleva Universal Fluoroscopic applications

    Reason

    The delivered application software was an outdated version to the model of equipment.

    Action

    Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.

    Distribution

    Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

    Quantity

    19 devices