Events

Retiro De Equipo (Recall) de Philips SureSigns Vital Signs 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 Healthcare 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
    53688
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0373-2010
  • Fecha de inicio del evento
    2009-10-30
  • Fecha de publicación del evento
    2009-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86326
  • 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
    Electrocardiograph - Product Code MHX
  • Causa
    Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker.
  • Acción
    Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377. On December 14, the firm issued the follow-up notification letter implementing the action plan to provide the software upgrade kit for installation and instructions.

Device

Philips SureSigns Vital Signs Monitors
  • Modelo / Serial
    Software Versions: A.02.33, A.01.18, A.00.34, A.00.28, and A.00.26
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates
  • Descripción del producto
    SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time || Part number: 863069,863070,863071,863072,863073,863074,453564041251,453564041261, || 453564041271,453564041281,453564041291, || 453564041301 || The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA