BEUDAMED
    FDA Recall Terminated

    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

    Recall: Z-0126-2014 · Initiated June 6, 2013

    Recall

    Recall Number
    Z-0126-2014
    Event Number
    65469
    Firm
    Carestream Health, Inc.
    FEI Number
    1315356
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2013
    Posted
    October 31, 2013
    Terminated
    May 20, 2016
    Address
    150 Verona Street, Rochester, NY, 14608-1733

    Description

    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

    Reason

    Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

    Action

    On June 6, 2013 Carestream Health Inc. initiated a recall for the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health Inc. will replace the power plug in all potentially impacted DRX-Revolution Mobile X-Ray Systems. Your Carestream service representative will contact you to answer any questions and schedule a visit to replace the plug of your Mobile X-Ray System as soon as possible. If you have any questions or concerns, or if you experience any issue with your plug prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.

    Distribution

    Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.

    Quantity

    180 units