BEUDAMED
    FDA Recall Terminated

    Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037

    Recall: Z-0364-2016 · Initiated August 19, 2014

    Recall

    Recall Number
    Z-0364-2016
    Event Number
    69090
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 19, 2014
    Terminated
    June 14, 2016
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037

    Reason

    The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

    Action

    The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.

    Distribution

    Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.

    Quantity

    1517 systems, not all units have the patient support accessory