Events

Retiro De Equipo (Recall) de Device Recall ExacTrac 6.0

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 Brainlab AG.

¿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
    67719
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1513-2014
  • Fecha de inicio del evento
    2014-02-24
  • Fecha de publicación del evento
    2014-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126143
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    When using multiple radiation treatment targets within a single plan, the exactrac v.6.0.3 might position the patient to an unintended radiation treatment point. as a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
  • Acción
    A FIELD SAFETY NOTICE / PRODUCT INFORMATION letters, dated February 24, 2014, were sent to all direct accounts. The letter identified the affected product, the reason for the recall, and included instructions for direct accounts to take while a permanent fix can be deployed. The letter also advised that a software update will be made available starting the end of April 2014. Customers with questions or concerns can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall ExacTrac 6.0
  • Modelo / Serial
    ExacTrac version v.6.0.3.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
  • Descripción del producto
    ExacTrac 6.0 is a patient positioning and monitoring system. || Model/catalogue numbers: || 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE || 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 || 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) || 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC || 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) || 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) || 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED || 49973B ET DATA PREP / REVIEW SYSTEM || 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT || 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY || 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Dirección del fabricante
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    USFDA