BEUDAMED
    FDA Enforcement Class II Terminated

    Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608

    Recall: Z-1138-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1138-2017
    Event ID
    76134
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    January 12, 2017
    Classification Date
    February 3, 2017
    Termination Date
    June 13, 2018
    Address
    150 Verona St, N/A, Rochester, NY, 14608-1733, United States

    Description

    Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608

    Reason

    The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.

    Code Info

    Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    US: 1403 units; Foreign: 1370 units