BEUDAMED
    FDA Enforcement Class II Ongoing

    Discovery XR656 HD. X-Ray imaging system.

    Recall: Z-1045-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1045-2025
    Event ID
    96208
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    February 12, 2025
    Initiation Date
    January 28, 2025
    Classification Date
    February 3, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Discovery XR656 HD. X-Ray imaging system.

    Reason

    The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

    Code Info

    Definium Tempo (GTIN: 00195278118356) Definium Tempo Pro (GTIN: 00195278070265)

    Distribution

    Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    3149 (1697 US; 1452 OUS)