Events

Retiro De Equipo (Recall) de Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS)

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 Medical Systems Information Technologies, Inc..

¿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
    78918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0487-2018
  • Fecha de inicio del evento
    2018-01-11
  • Fecha de publicación del evento
    2018-01-25
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160858
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Causa
    Carescape central station (cscs) software version 2.0.2 units may experience unexpected no comm (no communication) and network communication issues after boot-up or system restart.
  • Acción
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and email to its consignees on 01/11/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions and follow the safety instructions. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative.

Device

Device Recall GE HEALTHCARE CARESCAPE Central Station (CSCS)
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
  • Descripción del producto
    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 || The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.
  • Manufacturer
    GE Medical Systems Information Technologies, Inc.

Manufacturer

GE Medical Systems Information Technologies, Inc.
  • Dirección del fabricante
    GE Medical Systems Information Technologies, Inc., 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA