Events

Retiro De Equipo (Recall) de Device Recall Brainlab

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
    70657
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1316-2015
  • Fecha de inicio del evento
    2015-02-16
  • Fecha de publicación del evento
    2015-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134353
  • 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
    The exactrac 6.X patient positioning system may incorrectly position the patient when using the exactrac cone beam ct (cbct) with a truebeam-specific optional subvolume-cbct.
  • Acción
    BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. Brainlab provided existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian TrueBeam system) with the product notification information. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customer starting August 2015 to schedule the update installation. For further questions please call Customer Hotline + 49 89 99 15 68 44 or 1-800 597-5911 ( For US Customers only)

Device

Device Recall Brainlab
  • Modelo / Serial
    ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0.   Model/Catalog Numbers:   49971, CBCT IMPORT & ALIGNMENT SOFTWARE;  20836, EXACTRAC 6.0 VARIAN CBCT LICENSE;   The software may be contained in configured items:   48320, ET UPGRADE SOFTWARE 6.0 TO 6.1;  48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA;  49973B, ET DATA PREP / REVIEW SYSTEM;  49973A, ET DATA PREP / REVIEW SYSTEM;  49973, ET DATA PREP / REVIEW SYSTEM;  49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT;  48302, ET DATA PREP / REVIEW SYSTEM
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
  • Descripción del producto
    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
  • Manufacturer
    Brainlab AG

Manufacturer

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