Events

Retiro De Equipo (Recall) de ElectriCord

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 GE Medical Systems Information Technologies.

¿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
    26293
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0011-04
  • Fecha de inicio del evento
    2003-04-30
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27445
  • 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 (Without Arrhythmia Detection Or Alarms) - Product Code MWI
  • Causa
    Reports of broken plug ground pins on ac power cords for patient monitors.
  • Acción
    The recalling firm mailed a Recall Notification Letter with response form and corretive power cords beginning on April 30, 2003 until August 14, 2003 as corrective cords became available. Consignees were instructed on how to determine if they have the recalled cords and to destroy any found by cutting the plug from the wire. Also corrective AC power cords were provided to each consignee.

Device

ElectriCord
  • Modelo / Serial
    Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.
  • Descripción del producto
    Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies
  • Dirección del fabricante
    GE Medical Systems Information Technologies, 4502 Woodland Corporate Blvd., Tampa FL 33614
  • Source
    USFDA