Events

Retiro De Equipo (Recall) de ApexPro 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
    36034
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0055-2007
  • Fecha de inicio del evento
    2006-08-04
  • Fecha de publicación del evento
    2006-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47766
  • 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
    When a patient being monitored with apexpro/apex pro ch telemetry with st monitoring disabled 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 (clinical information center) does not occur.
  • Acción
    An Urgent Medical Device Correction letter dated August 04, 2006 was sent to customers with affected devices. The letter described the issue affecting devices containing software versions v3.8 and earlier, provides short term recommendations and a long term solution of updating the software.

Device

ApexPro Telemetry System
  • Modelo / Serial
    Software version 3.8 and earlier
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA and Puerto Rico and countries of ,Australia, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Hunary, India, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerlant, Syria, Taiwan, Thailand, Tunisia, and Venezuela.
  • Descripción del producto
    GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)
  • 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