Retiro De Equipo (Recall) de Device Recall EasyDiagnost 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 North America Co. Phillips.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Stationary X-ray or Solid X-ray Imager - Product Code KPR
  • Causa
    Potential for bright artifacts to appear on the patient image from a previous exposure.
  • Acción
    On July 9, 2008, Philip Medical System began sending out the URGENT-Device Correction letter to their consignees. This letter describes the recalled product as EasyDiagnost Eleva with DRF system with SW release 1.0. The firm informs the consignees that under special circumstances there is a small possibility that bright artifacts appear on a patient image from a previous exposure. The consignees are advised to take care about the X-ray field limitation. If the detector is not affected by direct radiation, no problem will occur. If direct radiation reaches the detector, the collimation should not be too tight, such that the area of direct radiation is larger than 1.2 inch x 1.2 inch (or 30 mm x 30 mm). The minimum area is needed to detect and prevent memory artifacts. The firm will upgrade any affected products with the Field Change Order (FCO)70600031 and it will be implemented before the end of December 2008. The upgrade software is 1.0.3. The correction would be free of charge and the consignees should contact Philips Call Center at 800-772-9377, #5, #2.


  • Modelo / Serial
    Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Product was distributed in AZ, CA, FL and WA.
  • Descripción del producto
    The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
  • Manufacturer


  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source