BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Revolution EVO X-ray system

    Recall: Z-2181-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2181-2017
    Event ID
    77377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    May 19, 2017
    Classification Date
    June 12, 2017
    Termination Date
    July 29, 2018
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Revolution EVO X-ray system

    Reason

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

    Code Info

    n/a

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

    Quantity

    10,884