BEUDAMED
    FDA Enforcement Class II Ongoing

    Revolution EVO, Optima CT660, Optima CT680 CT Systems.

    Recall: Z-1900-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1900-2021
    Event ID
    88116
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    June 14, 2021
    Classification Date
    June 25, 2021
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Revolution EVO, Optima CT660, Optima CT680 CT Systems.

    Reason

    Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

    Code Info

    Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2

    Distribution

    3,665 (US = 956; OUS = 2,709)

    Quantity

    3665