BEUDAMED
    FDA Recall Terminated

    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas

    Recall: Z-0132-2014 · Initiated June 19, 2013

    Recall

    Recall Number
    Z-0132-2014
    Event Number
    65586
    Firm
    Carestream Health Inc.
    FEI Number
    1315356
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 19, 2013
    Posted
    November 1, 2013
    Terminated
    May 20, 2016
    Address
    150 Verona St, Rochester, NY, 14608-1733

    Description

    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas

    Reason

    Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.

    Action

    The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.

    Distribution

    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.

    Quantity

    331 units