BEUDAMED
    FDA Recall Terminated

    Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system

    Recall: Z-0884-2013 · Initiated October 25, 2012

    Recall

    Recall Number
    Z-0884-2013
    Event Number
    63674
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 25, 2012
    Posted
    February 26, 2013
    Terminated
    March 31, 2014
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system

    Reason

    When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.

    Action

    Philips Medical Systems issued on October 25, 2012 an Urgent Field Safety Notice for the Digital Diagnost System informing consignees of the software upgrade. The UFSN described the problem, the hazard involved, the action to be taken by the consumer/user and the action planned by Philips. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.

    Distribution

    Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.

    Quantity

    551