Events

Retiro De Equipo (Recall) de Device Recall Philips Healthcare

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
    73209
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0853-2016
  • Fecha de inicio del evento
    2016-01-04
  • 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=143570
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    The st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the host monitor.
  • Acción
    Philips Healthcare issued the Field Safety Notice on January 4, 2016, and informed 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. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Until your software is upgraded, please make sure that the ST Analysis is switched ON when using STE measurement in the Hexad 12-lead ECG Monitoring. This can be done by entering the ST Analysis Menu and select ST Analysis to On. For more detailed information, please refer to the Instructions for Use (IFU) of your host monitor or to the X2 Measurement Module IFU. Philips will provide a software correction free of charge. For further questions please call (978) 659-3000.

Device

Device Recall Philips Healthcare
  • Modelo / Serial
    Software Revision:K.21.54 or L.00.96
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • Descripción del producto
    Philips IntelliVue Measurement Module X1 || Model: M3001A
  • 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