Events

Retiro De Equipo (Recall) de Philips Avalon Monitors

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 Medical Systems, Inc..

¿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
    69348
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0105-2015
  • Fecha de inicio del evento
    2014-10-03
  • Fecha de publicación del evento
    2014-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130271
  • 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
    System, monitoring, perinatal - Product Code HGM
  • Causa
    Philips intellivue and avalon fetal monitors in time-synchronized automatic/sequence mode, the nbp automatic measurement series is stopped.
  • Acción
    Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a software upgrade free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: During the interim period until the SW is upgraded please make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. Please review this information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.

Device

Philips Avalon Monitors
  • Modelo / Serial
    software revision J.30.58:
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
  • Descripción del producto
    Philips Avalon Monitors with software revision J.30.58: || Model Product || FM20 M2702A ; || FM30 M2703A ; || FM50 M2705A || Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Dirección del fabricante
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA