Events

Retiro De Equipo (Recall) de 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
    67926
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1707-2014
  • Fecha de inicio del evento
    2014-04-15
  • Fecha de publicación del evento
    2014-06-03
  • 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=126619
  • 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 a specific plan update workflow in combination with a non-brainlab treatment planning system (tps), there is a possibility in exactrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
  • Acción
    Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

ExacTrac
  • Modelo / Serial
    ExacTrac software version 5.5.5 is included in the following model / catalog numbers:   1) 20818B ET SOFTWARE 5.5.5;  2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5;  3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5;  4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5;  5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5;  6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5;  7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5;  8) 49660A ET INFRARED SOFTWARE 5.5.5;  9) 49961 ET DATA PREP/REVIEW SYSTEM;  10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT;  11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT;  12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT;  13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT;  14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT;  15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
  • Descripción del producto
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
  • Manufacturer
    Brainlab AG

Manufacturer

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