Events

Retiro De Equipo (Recall) de Philips Healthcare SureSigns VSi/VS2

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
    62865
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2303-2012
  • Fecha de inicio del evento
    2012-08-15
  • Fecha de publicación del evento
    2012-08-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111900
  • 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, measurement, blood-pressure, non-invasive - Product Code DXN
  • Causa
    Philips suresigns vsi/vs2+ patient monitors may not be properly secured and may fall from the wall mount.
  • Acción
    Philips sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers using the VSi/VS2+ with the GCX wall mount are instructed to complete and fax a Customer Reply Wall Mount Order Card to the Business Unit or Key Market indicating the number of wall mounts in use. Upon receipt of the Customer Reply Wall Mount Order Card, Philips will send a replacement of the mounting hardware. Customers should contact their local Philips representative for questions regarding this recall.

Device

Philips Healthcare SureSigns VSi/VS2
  • Modelo / Serial
    Serial Number Range CN14800101-CN14801360  CN21201362-CN21202440, CN21202525, SP13701043, USPP101007
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    Philips SureSigns VSi/VS2+ patient monitors || Model Part Numbers || VSi/ 863275, 863276, 863277, || VS2+ 863278, 863279. || The SureSigns VS2+ vital signs monitor is 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. The SureSigns VSi vital signs monitor is for measurement 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