Retiro De Equipo (Recall) de Device Recall Precedence

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.

¿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
    Computed Tomography X-Ray System - Product Code JAK
  • Causa
    Philips healthcare nuclear medicine determined that the detector arm assembly could be compromised.
  • Acción
    Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.


  • Modelo / Serial
    Catalog number 882351; Model numbers (3/8): 4535-602-53551,2169-3002A;  Serial numbers: 3000039 KP06090002 KP05070002 3000034 3000038 3000027  Model numbers (5/8); 4535-602-53561,2169-3003A. Serial number: KP06080001
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 || Philips Medical Systems || An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
  • Manufacturer


  • Dirección del fabricante
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Empresa matriz del fabricante (2017)
  • Source