Events

Retiro De Equipo (Recall) de Device Recall Brilliance CT XRay System

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 (Cleveland) 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
    59383
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3281-2011
  • Fecha de inicio del evento
    2011-06-02
  • Fecha de publicación del evento
    2011-09-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102462
  • 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
    System, X-ray, Tomography, computed - Product Code JAK
  • Causa
    Component defect. philips medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the detector module system (dms) bolt on one (1) brilliance 64 ct x-ray unit. the firm initiated this action following philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the udms.
  • Acción
    Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.

Device

Device Recall Brilliance CT XRay System
  • Modelo / Serial
    Model #78231, 510(k) #K03326, Serial Number: 9592.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including PA
  • Descripción del producto
    Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. || The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA