Events

Retiro De Equipo (Recall) de Device Recall ApexPro FH Telemetry 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.

¿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
    35826
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0054-2007
  • Fecha de inicio del evento
    2006-06-23
  • Fecha de publicación del evento
    2006-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46967
  • 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
    Telemetry System - Product Code MHX
  • Causa
    System warning alarm failure: when a patient being monitored is in a pre-existing condition of continuous message or advisory level alarm preceding a system warning level alarm, the system warning audible alarm and flashing yellow border around the patient panel at the cic does not occur.
  • Acción
    An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.

Device

Device Recall ApexPro FH Telemetry System
  • Modelo / Serial
    Software versions v3.8 and earlier.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
  • Descripción del producto
    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Dirección del fabricante
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA