Events

Retiro De Equipo (Recall) de Device Recall Philips

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 Electronics North America Corporation.

¿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
    72571
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0764-2016
  • Fecha de inicio del evento
    2015-11-03
  • Fecha de publicación del evento
    2016-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141538
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Causa
    Normally, movement of the c-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the c-arc. because of improper adjustment and tolerances, when the c-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued c-arc movement (c-arc is looking for balanced position).
  • Acción
    The letters for the customers in the United States were sent on 11/3/2015, via certified return receipt and were addressed to the Risk Manager. Philips will perform a test on the 15 affected Allura Xper R8.2 FD 20C systems to see if the motion controller amplifier of the brake motor works correctly. If the test will not pass, the motor will be replaced. The Recall Package is sent to all Key Markets worldwide. The Key Market of an affected country will contact the facility where these systems were installed.

Device

Device Recall Philips
  • Modelo / Serial
    Ceiling version only.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.
  • Descripción del producto
    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA