Events

Retiro De Equipo (Recall) de Device Recall Philips Multi Diagnost Eleva II with swivel cable

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
    62052
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1829-2012
  • Fecha de inicio del evento
    2012-05-21
  • Fecha de publicación del evento
    2012-06-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109739
  • 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, angiographic - Product Code IZI
  • Causa
    Multidiagnost eleva x--ray system may have damage to system cables from repeated movement.
  • Acción
    Philips Healthcare Imaging issued Urgent Field Safety Notice dated May 21, 2012, to accounts informing an inspection will be performed of the unit. The Cable guiding plate will be replaced. If the cables show any damage the complete cable set wll also be replaced. No action is be taken by the customer. For further information customers should call 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips Multi Diagnost Eleva II with swivel cable
  • Modelo / Serial
    Units with cable swivel delivered from 2007
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom
  • Descripción del producto
    Philips Multi Diagnost Eleva II with swivel cable || Product Codes; || 708032, 708036 || Multi Diagnost Eleva with FlatDetector with swivel cable || Product Codes: 708034, 708037 || This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
  • 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