Events

Retiro De Equipo (Recall) de Device Recall Brainlab ExacTrac

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
    68741
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2146-2014
  • Fecha de inicio del evento
    2014-06-24
  • Fecha de publicación del evento
    2014-08-04
  • 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=128586
  • 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
    Brainlab ExacTrac - Product Code IYE
  • Causa
    When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions exactrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "ok" icon. if this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
  • Acción
    Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated June 24, 2014, to all affected customers. The letter included instructions for customers to: 1) Avoid using plans with multiple isocenters in ExacTrac 6.0.4 whenever possible, and 2) If plans with multiple isocenters cannot be avoided and such a plan is used in ExacTrac v.6.0.4, then always select "Yes" in the dialog displayed to "keep the previous correction shift" when switching between isocenters and always verify all final treatment positions. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact you to schedule the update within the next 6 months. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab ExacTrac
  • Modelo / Serial
    ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE;  2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE;  3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE;  4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE;  5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR);  6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR);  7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR);  8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED;  9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC;  10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4;  11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4;  12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R;  13) 49973B ET DATA PREP / REVIEW SYSTEM;  14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY;  15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED;  16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
  • Descripción del producto
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
  • Manufacturer
    Brainlab AG

Manufacturer

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