Events

Retiro De Equipo (Recall) de Pinnacle3 Radiation Therapy Planning 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
    63430
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0206-2013
  • Fecha de inicio del evento
    2012-10-05
  • Fecha de publicación del evento
    2012-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113761
  • 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, nuclear magnetic resonance imaging - Product Code IYE
  • Causa
    Philips medical systems cleveland), inc. is recalling pinnacle3 virtual client connection software version 3.1 due to an improper release and subsequent distribution.
  • Acción
    The firm, Philips Healthcare, sent a "Customer Information Letter" dated 2012 Oct 05. The letter listed the affected products, problem description, how to identify affected products, advise on actions by customer / user, actions planned by Philips and further information and support. The letter stated that no action is needed on the part of the customer. The field service engineer will be scheduling a site visit to complete the replacement. Philips Healthcare will be delivering the correct VCC kit. For customers in North America if you need any further information or support concerning this issue, please contact our Customer Care Solutions Center at 1-800-722-9377. Select option 5 for "All Imaging Systems". Enter your site ID # (If you do not have a site ID#, simply pause for a moment.). Select option 5 for "Nuclear Medicine" and finally select option 3 for "Pinnacle" support.

Device

Pinnacle3 Radiation Therapy Planning System
  • Modelo / Serial
    Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: ME, MI, NY, and WI.
  • Descripción del producto
    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. || Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
  • Manufacturer
    Philips Medical Systems (Cleveland), Inc.

Manufacturer

Philips Medical Systems (Cleveland), Inc.
  • Dirección del fabricante
    Philips Medical Systems (Cleveland), Inc., 5520 Nobel Dr Ste 125, Fitchburg WI 53711-4948
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA