Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging 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, LLC.

¿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
    66168
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2253-2013
  • Fecha de inicio del evento
    2013-06-19
  • Fecha de publicación del evento
    2013-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121602
  • 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
    Ge healthcare has recently become aware of a potential safety issue with respect to discovery igs 730 imaging systems. a patient data management error may prevent the discovery igs 730 imaging system from booting on start-up or re-booting during procedure. the boot issue may occur when a large amount of patient data remains in the browser and is not deleted. the inability to boot the system ma.
  • Acción
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 19, 2013 to its Consignees/customers. The letter described the Safety Issue, Safely Instructions, Affected Product Detail, Product Correction and Contact Information. The consignees were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call : United States: 800 437 1171. For other countries, please contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging System
  • Modelo / Serial
    Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.
  • Descripción del producto
    GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. || The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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