Events

Retiro De Equipo (Recall) de Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder

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 Integrated IT Solutions.

¿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
    49460
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0456-2009
  • Fecha de publicación del evento
    2008-12-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73474
  • 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
    Perinatal Monitoring System - Product Code HGM
  • Causa
    Software anomalies in the alert and reminder feature could result in a delay of treatment. when attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
  • Acción
    The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.

Device

Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder
  • Modelo / Serial
    software version 6.80.0 only with Alert and Reminder feature activated
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- state of Ohio.
  • Descripción del producto
    GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 || Intended for use as a clinical data management system.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Dirección del fabricante
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA