Events

Retiro De Equipo (Recall) de Device Recall Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor

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 ZOLL Medical 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
    67749
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1311-2014
  • Fecha de inicio del evento
    2014-03-05
  • Fecha de publicación del evento
    2014-03-31
  • 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=126205
  • 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
    Defibrillator/pacemaker/monitor may latch in a continuous device reset loop and cannot be used.
  • Acción
    Zoll Medical issued a Notification letter daetd March 5, 2014, to all affected consignees. The notification letter provides information on how to avoid the issue and instructs customers to contact ZOLL to get affected devices updated. Customers will be given the option to have a software upgrade kit sent to them to update their devices or return devices to ZOLL Service department in Chelmsford Massachusetts to have the device upgraded with the latest software release (Software version 02.16.04.00). Customers with questions were instructed to contact the 24/7 technical support numbers 1 (800) 348 9011 or +1 (978) 421 9460 to assist users with any aspect of this notice.

Device

Device Recall Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor
  • Modelo / Serial
    System Software Version 02.10.02.00 or Higher
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey.
  • Descripción del producto
    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
  • Manufacturer
    ZOLL Medical Corporation

Manufacturer

ZOLL Medical Corporation
  • Dirección del fabricante
    ZOLL Medical Corporation, 269 Mill Road, Chelmsford MA 01824
  • Empresa matriz del fabricante (2017)
    Asahi Kasei Corp.
  • Source
    USFDA