Events

Retiro De Equipo (Recall) de Digital Diagnost

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
    61528
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1464-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108354
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
  • Acción
    The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.

Device

Digital Diagnost
  • Modelo / Serial
    Model #s 712020, 712022, 712082 All systems with Eleva software version 2.x and stitching option.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.
  • Descripción del producto
    Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option || Intended use: Stationary radiographic system, Radiographic system, digital
  • 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