BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.

    Recall: Z-0881-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0881-2013
    Event ID
    63822
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    October 24, 2012
    Classification Date
    February 26, 2013
    Termination Date
    July 23, 2015
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.

    Reason

    Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project

    Code Info

    The EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 9127, 10331, 10348, 10402, 10705, 10749, 10827, 11002, 11362, 11365, 11588, 11597, 11652, 11693, 11704, 11724, 11725, 11828, 11857, 11861, 11945, 11949, 11950, 11951, 11952, 11953, 11954, 11955, 11956, 11957, and 11979.

    Distribution

    Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..

    Quantity

    39 units