BEUDAMED
    FDA Enforcement Class II Terminated

    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.

    Recall: Z-0844-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0844-2014
    Event ID
    67188
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    December 26, 2013
    Classification Date
    January 27, 2014
    Termination Date
    March 10, 2017
    Address
    1049 Ridge Rd W, Rochester, NY, 14615-2731, United States

    Description

    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.

    Reason

    Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.

    Code Info

    Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675

    Distribution

    worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.

    Quantity

    164 units Total (42 domestically & 122 internationally)