BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Medical System Allura Xper X-Ray Angiographic

    Recall: Z-1120-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1120-2015
    Event ID
    70011
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    June 6, 2014
    Classification Date
    March 2, 2015
    Termination Date
    October 15, 2021
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Medical System Allura Xper X-Ray Angiographic

    Reason

    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

    Code Info

    Software releases: PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2.

    Distribution

    Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada, China, Croatia, Czech Republic, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Reunion, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Saudi Arabia, Switzerland, Syria, Taiwan, Thailand, France, Dominican Republic, Colombia, Turkey, Germany, Greece, Hong Kong, Denmark, Ecuador, Egypt, Estonia, Finland, Vietnam, Russian Federation, Iran, Iraq, Ireland, Israel, Italy, India, Indonesia, Japan, Jordan, Kenya, South Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldavia, Mongolia, Morocco, Nepal, Ukraine, United Arab Emirates, and United Kingdom

    Quantity

    7439