Events

Recall of GE Brivo OEC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66341
  • Event Risk Class
    Class 2
  • Event Number
    Z-0066-2014
  • Event Initiated Date
    2013-09-18
  • Event Date Posted
    2013-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122081
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • 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.

Device

GE Brivo OEC
  • Model / Serial
    GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
  • Product 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.
  • Manufacturer
    GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD

Manufacturer

GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
  • Manufacturer Address
    GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD, No. 2 Yong Chang North Rd., Beijing Econ. & Tech. Dev. Zone, Beijing China
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA