Events

Retiro De Equipo (Recall) de Device Recall IntelliVue Clinical Information Portfolio (ICIP)

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.

¿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
    46961
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1541-2008
  • Fecha de inicio del evento
    2008-03-04
  • Fecha de publicación del evento
    2008-08-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68629
  • 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
    Display, Cathode-Ray Tube, Medical - Product Code DXJ
  • Causa
    Medications prescribed for one patient were printed on the record of another patient.
  • Acción
    Philips Medical issued letter notification, dated 29 Feb 2008 to customers titled; "Urgent Medical Device Correction Notice". Customers were asked to not solely rely on the Worklist to remind them when to administer orders or interventions until the software has been upgraded. Customers should review the reminders and verify orders and interventions on the Medication Administration Record and Administration record. The correction will be in the form of a software upgrade and will be performed remotely by Philips service personnel.

Device

Device Recall IntelliVue Clinical Information Portfolio (ICIP)
  • Modelo / Serial
    Version D.00.00
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE
  • Descripción del producto
    IntelliVue Clinical Information Portfolio || Critical Care Release D, Version D.00.00 || Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Dirección del fabricante
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA