BEUDAMED
    FDA Recall Terminated

    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.

    Recall: Z-1377-2015 · Initiated January 8, 2015

    Recall

    Recall Number
    Z-1377-2015
    Event Number
    70649
    Firm
    Carestream Health, Inc.
    FEI Number
    1317307
    Product Code
    MUH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 8, 2015
    Posted
    April 3, 2015
    Terminated
    April 20, 2017
    Address
    1049 W Ridge Rd, Rochester, NY, 14615-2731

    Description

    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.

    Reason

    Units device head descended unexpectedly

    Action

    The firm sent customers "Urgent: Medical Device Recall" letters, dated December 29, 2014. The letter described the problem, as well as, the actions to be taken. A Carestream Health service representative will contact customers to schedule a visit to inspect the affected devices. Questions or concerns should be directed towards the Carestream Customer Care Center in the U.S. at 1-800-328-2910.

    Distribution

    Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NV, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV; and the countries of India and Switzerland.

    Quantity

    3,110 units (863 domestically & 2,247 internationally)