Events

Retiro De Equipo (Recall) de Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504

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 Toshiba American Medical Systems 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
    62853
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2278-2012
  • Fecha de inicio del evento
    2008-05-13
  • Fecha de publicación del evento
    2012-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111875
  • 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
    The status display in the sequence queue window may not change from "current" to "done".
  • Acción
    A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.

Device

Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504
  • Modelo / Serial
    Models MRT-1503 and MRT-1504  " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. || Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA