BEUDAMED
    FDA Enforcement Class II Terminated

    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.

    Recall: Z-0066-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0066-2014
    Event ID
    66341
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    September 18, 2013
    Classification Date
    October 24, 2013
    Termination Date
    January 27, 2014
    Address
    No. 2 Yong Chang North Rd., Beijing Econ. & Tech. Dev. Zone, Beijing, N/A, N/A, China

    Description

    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.

    Reason

    GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.

    Code Info

    GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.

    Quantity

    29