BEUDAMED
    FDA Enforcement Class II Terminated

    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

    Recall: Z-1504-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1504-2016
    Event ID
    73776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2016
    Initiation Date
    March 4, 2016
    Classification Date
    April 15, 2016
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

    Reason

    The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

    Code Info

    M/N 882489; S/N: 66794, 66798, 66836, 66009,66011, 67154, 66828, 67058, 67050, 67031, 67284, 66332, 66335, 66397, 67026, 67040, 66084, 66089, 66092, 67007, 67011, 67226, 66956, 66454, 66447, 66413, 66129, 66128, 66300, 66023, 11728, 66000, 66938, 67270, 67252, 66571, 66443, 66324, 66869, 68477, 66682, 66815, 66284, 67263, 66265, 66277, 66880, 66892, 66258, 66079, 66181, 66451, 66627, 66187, 66806, 67016, 67008, 66706, 66745, 66817, 66822, 66910, 66908, 66811, 67087, 67094, 66241, 66825, 66632, 66624, 66854, 66689, 66690, 66906, 66792, 67173, 67069, 67166, 68290, 67182, 66785, 67292, 67286, 66768, 66769, 66550, 66113, 67220, 67193, 67186, 66657, 66668, 66564, 66065, 67065, 67208, 67204, 66818, 66819, 67122, 66818, 66819, 66456, 67212, 66019, 67057, 67172, 67157, 67167, 67162, 66737, 68361, 66183, 66368, 66387, 66376, 66415, 66136, 66137, 66960, 66958, 67142 & 67165.

    Distribution

    Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.

    Quantity

    126 Units