Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare Precision RXi 23A/32A Analog System

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.

¿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
    71574
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2121-2015
  • Fecha de inicio del evento
    2015-06-12
  • Fecha de publicación del evento
    2015-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138742
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    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.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor(s). 1. Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2. Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. 3. Contact your GE Healthcare representative to inform them of any loose or missing screws. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare Precision RXi 23A/32A Analog System
  • Modelo / Serial
    Mfg Lot or Serial # 00000001386MC2 00000002109MC7 00000001010MC8 00000001337MC5 00000002212MC9 00000001720MC2 00000001098MC3 00000001454MC8 00000001082MC7 00000001266MC6 00000001656MC8 00000003661MC6
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    GE Healthcare Precision RXi 23A/32A Analog System
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA