Events

Retiro De Equipo (Recall) de Device Recall eCare Coordinator

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 Philips Visicu.

¿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
    76660
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1708-2017
  • Fecha de inicio del evento
    2017-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153766
  • 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
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • Causa
    Ecarecoordinator (ecc) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. the software is intended to provide patient information from the patient location through networking technology to a remote care team. a software defect was discovered in the philips ecarecoordinator (ecc) clinical user interface that can at times cause missing or redundant data to be saved without notification to the user.
  • Acción
    Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction.

Device

Device Recall eCare Coordinator
  • Modelo / Serial
    453564506091  eCareCoordinator
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Nationwide
  • Descripción del producto
    eCare Coordinator || Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
  • Manufacturer
    Philips Visicu

Manufacturer

Philips Visicu
  • Dirección del fabricante
    Philips Visicu, 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA