BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0126-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0126-2014
    Event ID
    65469
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    June 6, 2013
    Classification Date
    October 31, 2013
    Termination Date
    May 20, 2016
    Address
    150 Verona Street, N/A, Rochester, NY, 14608-1733, United States

    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.

    Code Info

    Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490

    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