Events

Retiro De Equipo (Recall) de Device Recall Philips MutliDiagnost Eleva FD

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
    Recall
  • ID del evento
    45959
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1137-2008
  • Fecha de inicio del evento
    2007-11-29
  • Fecha de publicación del evento
    2008-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66580
  • 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
    fluoroscopic x-ray system - Product Code JAA
  • Causa
    Delay in imaging: multidiagnost eleva with flat detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. the loss of system availability could occur during an interventional.
  • Acción
    On 11/29/07 Philips Medical Systems sent a letter dated 11/28/07 to customers stating that if users perform certain image file housekeeping operations, fluoroscopy cannot be performed and new exposures cannot be acquired until those operations are complete. It also instructs that the unavailability of fluoroscopy and exposure can be avoided by not pressing the "Delete All Images" button until any pending Autopush operation is complete. FCO 70800067 will be issued to service representatives to install new software.

Device

Device Recall Philips MutliDiagnost Eleva FD
  • Modelo / Serial
    Sysco Software Version 2, release 4.1.1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Distribution - CO, MN, NC, NJ and TX.
  • Descripción del producto
    MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, || Bothell, WA, 98021
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

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