Events

Retiro De Equipo (Recall) de Device Recall Central Station Monitor

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. Cardiac & Monitoring 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
    25430
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0595-03
  • Fecha de inicio del evento
    2003-01-02
  • Fecha de publicación del evento
    2003-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25819
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Central station monitoring information centers may experience sreeen freeze, i.E. loss of display, keyboard or mouse lock up.
  • Acción
    Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.

Device

Device Recall Central Station Monitor
  • Modelo / Serial
    Serial# 4102A00874 4102A00889 4102A00890 4102A00894 4102A00905 4102A00920 4102A00945 4102A00957 4102A00971 4102A00972 4102A00984 4102A01011 4102A01029 4102A01030 4102A01031 4102A01032 4136A01100 4136A01101 4136A01102 4136A01103 4136A01104 4136A01105 4136A01106 4136A01116 4136A01117 4143A01190 4143A01191 4143A01192 4143A01213 4143A01227 4143A01244 4143A01289 4143A01290 4143A01291 4143A01292 4143A01311 4143A01312 4213A01338 4213A01345 4213A01346 4213A01383 4213A01386 4213A01398 4213A01399 4213A01400 4213A01401 4213A01402 4213A01403 4213A01404 4213A01405 4213A01406 4213A01407 4213A01412 4213A01416 4213A01420 4213A01421 4213A01425 4213A01442 4213A01452 4213A01468 4213A01472 4213A01479 4213A01481 4213A01482 4213A01483 4213A01484 4213A01485 4213A01486 4213A01490 4213A01491 4143A01175 4143A01249 4143A01250 4143A01251 4143A01252 4143A01253 4213A01347 4143A01178 4213A01469 4102A00903 4102A00904 4102A00892
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    Nationwide Canada, Europe, Asia, Latin America
  • Descripción del producto
    Viridia/Agilent Information Center || Model : M3151A#CO1
  • Manufacturer
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems

Manufacturer

Philips Medical Systems, Inc. Cardiac & Monitoring Systems
  • Dirección del fabricante
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems, 3000 Minuteman Road, Andover MA 01810
  • Source
    USFDA