BEUDAMED
    FDA Recall Terminated

    Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.

    Recall: Z-1462-2012 · Initiated April 2, 2012

    Recall

    Recall Number
    Z-1462-2012
    Event Number
    61514
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 2, 2012
    Posted
    April 25, 2012
    Terminated
    May 9, 2014
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.

    Reason

    The monitor Ceiling suspension may fail, which may cause the monitor to drop.

    Action

    Philips sent an "URGENT-FIELD SAFETY NOTICE" dated March 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides information for continued safe and proper use of the equipment. Contact your local Philips representative at 866-767-2822 for further support regarding this issue. Recall expanded 5-2013 to additional 460 units distributed worldwide.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Belgium, Brazil, Canada, Czech Rep, Chili, China, Columbia, Denmark, Egypt, France, Germany, India, Indonesia, Italy, Japan, Malaysia, Mexico, Morocco, Netherlands, Oman, Russia, Saudi Arabia, Singapore, South Korea, Spain, Thailand, United Kingdom, and Vietnam.

    Quantity

    145