BEUDAMED
    FDA Recall 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 · Initiated December 26, 2013

    Recall

    Recall Number
    Z-0844-2014
    Event Number
    67188
    Firm
    Carestream Health, Inc.
    FEI Number
    1317307
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    December 26, 2013
    Posted
    January 27, 2014
    Terminated
    March 10, 2017
    Address
    1049 Ridge Rd, W Rochester, NY, 14615-2731

    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.

    Action

    On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of detector calibration. Customers will questions can call 1-800-328-2910 7 days per week on a 24 hour basis.

    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)