BEUDAMED
    FDA Enforcement Class II Terminated

    UroDiagnost; x-ray system. Product Code: 708033

    Recall: Z-2306-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2306-2016
    Event ID
    74731
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    July 19, 2016
    Classification Date
    August 1, 2016
    Termination Date
    October 8, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    UroDiagnost; x-ray system. Product Code: 708033

    Reason

    The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

    Code Info

    All serial numbers. 708033 System serial numbers 1, 17, 15, 4, 3, 7, 18, 21, 8, 13, 14, 11, 5, 16, 2.

    Distribution

    Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.

    Quantity

    993 total