Events

Retiro De Equipo (Recall) de Device Recall Nemio XG SSA580A, Diagnostic Ultrasound 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 Toshiba American Med Sys 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
    37813
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0771-2007
  • Fecha de inicio del evento
    2006-12-19
  • Fecha de publicación del evento
    2007-05-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51592
  • 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
    Diagnostic Ultrasound System - Product Code ITX
  • Causa
    Transducer surface temperature : it was found during testing that when using the system in the 2dcdi + pw mode, with the scale graph function active, that the transducer surface temperature could exceed the 27 degrees celsius limit as specified in the iec safety standard.
  • Acción
    Notification letters were sent to customers on December 19, 2206. Customers were instructed to avoid using Scale Graph function with live images, and instructed to call up the Scale Graph after images are frozen. Customers were informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.

Device

Device Recall Nemio XG SSA580A, Diagnostic Ultrasound System
  • Modelo / Serial
    Serial #: A1A0642100; A1A0642102; A1B0662183; A1B0662184; A1B0662256; A1B0662257; A1B0662258; A1B0662327; A1B0662328; A1B0662330; A1B0662331; A3A0652115; A3B0662284; A3B0662285; A3B0662286; A3B0662287; A3B0662288; A3B0662289; A3B0662290; A3B0662291; A3B0662292; A3B0662293; A3B0662371; A3B0662372; A3B0662373; A3B0662374; A3B0662375; A3B0662376; A3B0662377; A3B0662378; A3B0662379; A3B0662380; A3B0672415; A3B0672416; A3B0672417; A3B0672418; A3B0672419;
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI.
  • Descripción del producto
    Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Dirección del fabricante
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA