BEUDAMED
    FDA Recall Terminated

    Head Holder shipped with Ingenuity Core 128 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-2204-2015 · Initiated March 17, 2015

    Recall

    Recall Number
    Z-2204-2015
    Event Number
    71227
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 17, 2015
    Posted
    July 22, 2015
    Terminated
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Head Holder shipped with Ingenuity Core 128 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

    A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.

    Action

    On 6/4/2015, the firm mailed Customer Information Letters.

    Distribution

    Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.

    Quantity

    55 units