BEUDAMED
    FDA Recall 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 · Initiated September 18, 2013

    Recall

    Recall Number
    Z-0066-2014
    Event Number
    66341
    Firm
    GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD No. 2 Yong Chang North Rd. Beijing Econ. & Tech. Dev. Zone Beijing China
    FEI Number
    3002175190
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 18, 2013
    Posted
    October 24, 2013
    Terminated
    January 27, 2014

    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.

    Action

    GE Healthcare sent an Urgent Medical Device Correction letter dated September 18,2013, to all affected customers to inform them of the issue and provide instructions for immediate mitigation of the issue. Customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions. Customers with questions were instructed to call 1-800-874-7378 option 8. For questions regarding this recall call 801-295-4952.

    Distribution

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

    Quantity

    29