BEUDAMED
    FDA Recall Terminated

    UroDiagnost; x-ray system. Product Code: 708033

    Recall: Z-2306-2016 · Initiated July 19, 2016

    Recall

    Recall Number
    Z-2306-2016
    Event Number
    74731
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 19, 2016
    Terminated
    October 8, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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

    Action

    On July 19, 2016, Philips sent a Field Safety Notice to all affected customers. Philips Field Service Engineers will add an independent safety catch free of charge.

    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