Retiro De Equipo (Recall) de GE Brivo OEC

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66341
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0066-2014
  • Fecha de inicio del evento
    2013-09-18
  • Fecha de publicación del evento
    2013-10-24
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-01-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • Causa
    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.
  • Acción
    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

  • Modelo / Serial
    GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
  • Descripción del producto
    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

Manufacturer

  • Dirección del fabricante
    GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD, No. 2 Yong Chang North Rd., Beijing Econ. & Tech. Dev. Zone, Beijing China
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA