Events

Retiro De Equipo (Recall) de Device Recall Philips Easy Diagnost ClassicStationary 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 Healthcare 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
    62568
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2208-2012
  • Fecha de inicio del evento
    2012-07-11
  • Fecha de publicación del evento
    2012-08-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111064
  • 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
    Table, radiographic, tilting - Product Code IXR
  • Causa
    Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.
  • Acción
    Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For further questions customers were instructed to call their Phillips representataive Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-687-1501

Device

Device Recall Philips Easy Diagnost ClassicStationary xray system
  • Modelo / Serial
    Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.
  • Descripción del producto
    Philips Easy Diagnost Classic-Stationary x-ray system || Catalog Numbers: 70642, 70643, 706030, 706031, 706032 || Stationary x-ray system, Universal RF system for general use.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA