Events

Retiro De Equipo (Recall) de Device Recall INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100

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
    53989
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0780-2010
  • Fecha de inicio del evento
    2009-12-07
  • Fecha de publicación del evento
    2010-02-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86994
  • 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 LNH
  • Causa
    Polymeric rf connector block on the tabletop overheated and eventually ignited during scanning due to combination of arcing of electrical components associated with the rf trap assembly located below the connector and flame rating of the connector block material.
  • Acción
    An "Urgent-Field Safety Notice" dated December 4, 2009 was issued via certified mail to customers. The notification letter described the affected product, problem, hazard involved and action to be taken by customer. The customer will ensure to maintain frequent contact with patients during scanning and that the patient comfort kit is installed for all patient studies. The Customer will be visited by a Philips Service Representative to inspect their MRI System and install the newly remanufactured RF Connector Block. Additionally, step-by-step trap/cable installation instructions including pictures are being drafted to ensure correct installation of cabling. If you need any further information or support concerning this issue, please contact your local Philips representative or 1-800-722-9377.

Device

Device Recall INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
  • Modelo / Serial
    Model #781230. All lots
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution- United states: (AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, LA, MA, MD, ME, MN, MO, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA & WI), ARGENTINA, BRAZIL, CANADA, CHINA, CYPRUS, FRANCE, GERMANY, GREECE, ITALY, JAPAN, KOREA, NEW ZEALAND, PAKISTAN, POLAND, RUSSIA, SWITZERLAND, TAIWAN & UNITED KINGDOM.
  • Descripción del producto
    MRI Eclipse 1.5T System Model #781230. || The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
  • 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