Events

Retiro De Equipo (Recall) de Device Recall Philips Imaging

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
    61779
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1689-2012
  • Fecha de inicio del evento
    2012-05-02
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109064
  • 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, mobile - Product Code IZL
  • Causa
    Unexpected low-level x-ray pulse.
  • Acción
    Philips sent a Urgent Field Safety Notice dated April 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of the communication. Please retain a copy with the equipment instruction for Use. A Philips Service Engineer will contact account as soon as the Field Action Kit is ready to be implemented. Communicate with Philips with regard to this program, please reference Field Change Order 70400049. Further questions please contact your local Philips representative at 1-800-722-9377. On 2/6/15, Philips reported that the recall was extended to an additional 88 units that were unit stock that did receive the correction. Philips issued recall notifcation letter (FCO70400049) on 1/20/2015 to users. Control boards will replaced by a Philips Service Engineer.

Device

Device Recall Philips Imaging
  • Modelo / Serial
    Serial numbers: PC1-0504 through PC1 -0588. Extended recall 1/20/2015 (88 units): 484947/SNPC1-0579 375495 423986/SNPC1-0406 423986/SNPC1-0406 423990/SNPC1-0410 465801/SNPC1-0499 465801/SNPC1-0499 365636 365637 365637 365635 392508/SNPC1-0281 479454/SNPC1-0559 352064 352064 323714 455129/SNPC1-0474 423985/SNPC1-0396 423985/SNPC1-0396 411312/SNPC1-0343 411312/SNPC1-0343 328312 328312 345399 345399 345402 345402 345402 380754 380754 424721/SN424721PC1 380965 312998 PC1-0265 314440 314440 386105/SNPC1-0272 425484/SNPC1-0401 425484/SNPC1-0401
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-- USA ( nationwide ) including the states of IA, LA, LA, ND, NY, OH and TX and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Germany, Hong Kong, Indonesia, Italy, Malaysia, Mexico, Netherlands, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Africa,Thailand and Ukraine.
  • Descripción del producto
    Philips Practix Convenio Mobile X-ray System || Model: 70455 || The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical 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