Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, Precision MPi fluoroscopic imaging systems.

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-2123-2015
  • 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=138744
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 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 MPi fluoroscopic imaging systems.
  • Modelo / Serial
    Mfg Lot or Serial # 00000000687MC4 00000001286MC4 00000004134MC3 00000003843MC0 00000003890MC1 00000004159MC0 00000004689MC6 00000001505MC7 00000003889MC3 00000003937MC0 00000002207MC9 00000003931MC3 00000001452MC2 00000003847MC1 00000004427MC1 00000004649MC0 00000003642MC6 00000001343MC3 00000004650MC8 00000004161MC6 00000001459MC7 00000001658MC4 00000001333MC4 00000003511MC3 00000001430MC8 00000001057MC9 00000001055MC3 00000001275MC7 00000001420MC9 00000001406MC8 00000001889MC5 00000001408MC4 00000003936MC2 00000001101MC5 00000001415MC9 00000001746MC7 00000001419MC1 00000004701MC9 0000000470FMC9 00000004700MC1 00000000952MC2 00000001302MC9 00000000921MC7
  • 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 MPi fluoroscopic imaging systems.
  • 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