BEUDAMED
    FDA Enforcement Class II Terminated

    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

    Recall: Z-0179-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0179-2014
    Event ID
    66067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    August 29, 2013
    Classification Date
    November 7, 2013
    Termination Date
    June 28, 2016
    Address
    150 Verona St, N/A, Rochester, NY, 14608-1733, United States

    Description

    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

    Reason

    Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

    Code Info

    Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware

    Distribution

    Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.

    Quantity

    190 units