BEUDAMED
    FDA Recall Terminated

    Philips Multi Diagnost Eleva with FlatDetector

    Recall: Z-1045-2015 · Initiated October 14, 2013

    Recall

    Recall Number
    Z-1045-2015
    Event Number
    69870
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 14, 2013
    Posted
    February 26, 2015
    Terminated
    January 23, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Multi Diagnost Eleva with FlatDetector

    Reason

    The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

    Action

    Philips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by September 1, 2015. For further questions please call (978) 687-1501.

    Distribution

    Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.

    Quantity

    238