BEUDAMED
    FDA Recall Terminated

    Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    Recall: Z-1356-2016 · Initiated February 5, 2016

    Recall

    Recall Number
    Z-1356-2016
    Event Number
    73338
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 5, 2016
    Terminated
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    Reason

    The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

    Action

    Philips Medical Systems sent a Customer Information dated February 5, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. To correct the issue Philips will release field change orders (FCO) 72800652 and 72800644 to install a software update on the affected systems. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts). For questions regarding this recall call 440-483-2997.

    Distribution

    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

    Quantity

    82 Units