Events

Retiro De Equipo (Recall) de Device Recall XL Defibrillator

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 Electronics North America Corporation.

¿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
    79191
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0978-2018
  • Fecha de inicio del evento
    2018-02-07
  • 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=161567
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    Update xl¿ device software to version a.03. this includes enhancements to the operational checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.
  • Acción
    Philips is initiating a correction to affected devices. A software upgrade is available free of charge for all units affected by the issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Customers may continue to use XL+ prior to receiving the software upgrade. For further questions, please call (978) 659-3000.

Device

Device Recall XL Defibrillator
  • Modelo / Serial
    HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Foreign Only - China
  • Descripción del producto
    HeartStart XL+ Defibrillator/Monitor || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA