BEUDAMED
    FDA Recall Terminated

    Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital

    Recall: Z-1464-2012 · Initiated April 3, 2012

    Recall

    Recall Number
    Z-1464-2012
    Event Number
    61528
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 3, 2012
    Posted
    April 26, 2012
    Terminated
    March 13, 2014
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital

    Reason

    Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.

    Action

    The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.

    Quantity

    606 units