Retiro De Equipo (Recall) de Device Recall TSX101: Aquilion 32/64

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
    59519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3221-2011
  • Fecha de inicio del evento
    2010-12-08
  • Fecha de publicación del evento
    2011-09-16
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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, tomography, computed - Product Code JAK
  • Causa
    There is the potential that the current may not be controlled correctly in examinations using the ecg modulation function, which adjusts the x-ray output in synchronization with the ecg waveform.
  • Acción
    Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical group at their facility. Customers are also to complete and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshiba Representative at 800-521-1968.

Device

  • Modelo / Serial
    Units manufactured from January 2005 to September 2007
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA