Events

Retiro De Equipo (Recall) de Easy Diagnost Eleva

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..

¿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
    66705
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0431-2014
  • Fecha de inicio del evento
    2013-10-30
  • Fecha de publicación del evento
    2013-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123097
  • 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, x-ray, stationary - Product Code KPR
  • Causa
    The delivered application software was an outdated version to the model of equipment.
  • Acción
    Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.

Device

Easy Diagnost Eleva
  • Modelo / Serial
    706050, 706083, 706088
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
  • Descripción del producto
    Easy Diagnost Eleva || Universal Fluoroscopic applications
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Dirección del fabricante
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA