BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Precision RXi 23A/32A Analog System

    Recall: Z-2121-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2121-2015
    Event ID
    71574
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    June 12, 2015
    Classification Date
    July 20, 2015
    Termination Date
    August 3, 2017
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Precision RXi 23A/32A Analog System

    Reason

    A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.

    Code Info

    Mfg Lot or Serial # 00000001386MC2 00000002109MC7 00000001010MC8 00000001337MC5 00000002212MC9 00000001720MC2 00000001098MC3 00000001454MC8 00000001082MC7 00000001266MC6 00000001656MC8 00000003661MC6

    Distribution

    Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.

    Quantity

    788 (701 US; 87 OUS)