BEUDAMED
    FDA Recall Terminated

    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    Recall: Z-0882-2013 · Initiated October 24, 2012

    Recall

    Recall Number
    Z-0882-2013
    Event Number
    63822
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 24, 2012
    Posted
    February 26, 2013
    Terminated
    July 23, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    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

    Action

    Philips Medical issued an URGENT - Medical Device Correction letter to their customers concerning the Tumor LOC IPD issue on October 25, 2012. The letter informs the customer of the nature of this software problem and names the Brilliance and GEMINI scanning systems affected by this issue. The letter goes on to describe the hazard inherent to this software issue and provides 'Workaround procedures which the customers can use in order to help mitigate the effects of this problem. Customers with questions should contact their Customers Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 1-800-722-9377.

    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

    30 units