BEUDAMED
    FDA Recall Terminated

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    Recall: Z-0932-2014 · Initiated December 4, 2013

    Recall

    Recall Number
    Z-0932-2014
    Event Number
    67167
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 4, 2013
    Posted
    February 4, 2014
    Terminated
    February 2, 2016
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    Reason

    The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.

    Action

    On 12/4/2013, the firm sent Field Safety Noticies to their customers.

    Distribution

    Product was shipped to the following states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, NY , OH, OR, PA, TN, TX, VA, VT, WA & WI. Product was also shipped to the following countries: Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Cuba, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Ukraine, United Kingdom, Venezuela & Vietnam.

    Quantity

    386 units