BEUDAMED
    FDA Enforcement Class II Ongoing

    Proteus XR/a (SlOK : K993090)

    Recall: Z-2449-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2449-2019
    Event ID
    83647
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    October 2, 2019
    Initiation Date
    August 9, 2019
    Classification Date
    September 20, 2019
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Proteus XR/a (SlOK : K993090)

    Reason

    Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

    Code Info

    console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)

    Distribution

    Worldwide - US Nationwide

    Quantity

    647 US; 167 OUS