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
    68845
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2213-2014
  • Fecha de inicio del evento
    2014-05-21
  • Fecha de publicación del evento
    2014-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128845
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Causa
    Brainlab navigation software spine & trauma 3d 2.0/2.1 offers automatic registration of intraoperatively acquired ct image data sets. to enable automatic registration, the software requires the gantry position of the scanner. the gantry position can either be entered manually or submitted automatically from the ct scanner. if automatic gantry communication is available, the so-called ".
  • Acción
    The firm, Brainlab AG, sent "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letters dated May 21, 2014 to all consignees. The letters included instructions for consignees to: 1) not use Automatic Registration of iCT Data in combination with Siemens SOMATOM Definition AS CT scan (with Software Somaris SOM 7 or higher and Automatic Gantry Communication (available for Spine & Trauma 3D 2.0 and 2.1 only); 2) always make sure to perform careful accuracy verification according to the instructions in the Software User Guide; 3) Brainlab will perform corresponding service visits to change the gantry communication from automatic to manual to enable a safe and effective usage of this device combination, and 4) advise the appropriate personnel working in your department of the content of the letter. Customers with any questions can contact Brainlab via telephone at 800-597-5911 or e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab
  • Modelo / Serial
    Model/Catalog Number: 19061-03
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.
  • Descripción del producto
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 || Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. || The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
  • Manufacturer
    Brainlab AG

Manufacturer

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