Events

Retiro De Equipo (Recall) de Device Recall VVsky Navigation Platform

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
    48682
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2209-2008
  • Fecha de inicio del evento
    2007-11-12
  • Fecha de publicación del evento
    2008-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-07-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71856
  • 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
    Radiation Therapy Treatment System - Product Code MUJ
  • Causa
    Diameter of cables used for installation are to small for the applied current. if an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables.
  • Acción
    BrainLAB sent Product Notification letters dated 11/12/07 to their VectorVision Sky end users, informing them of the possible overload of electrical cables in VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels). The users were requested to perform an inspection of the medical power supplies and cabling on a regular basis. If anything suspicious is noted, they were directed to shut down the entire system and contact BrainLAB immediately. BrainLAB contacted each account shortly after the sending of the letter to arrange for the installation of small fuses/circuit breakers according to the specific load limits per device, which will open the circuit in case of overload on faulty circuits, and to exchange the low voltage cables that directly connect the medical power supply from 1.5 mm2 to 2.5 mm2 thickness to withstand the full 20 amp current in case of a failure. Any questions were directed to BrainLAB's customer hotline at 1-800-597-5911.

Device

Device Recall VVsky Navigation Platform
  • Modelo / Serial
    VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of Arizona, Connecticut t, Idaho, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin.
  • Descripción del producto
    VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany || Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Dirección del fabricante
    Brainlab AG, Ammerthalstrasse 8, Kirchheim B. Muenchen Germany
  • Source
    USFDA