Events

Retiro De Equipo (Recall) de NAVIGATION SOFTWARE ENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    107383
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-09
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    In the surface matching registration dialogue if "last solution" after acquisition of additional registration points is selected the software stores a different registration than the one displayed to the user for verification.

Device

NAVIGATION SOFTWARE ENT
  • Modelo / Serial
    Model Catalog: 22212::ENT UNLIMITED NAVIGATION SOFTWARE 1.0 (Lot serial: ); Model Catalog: 22211::ENT ESSENTIAL NAVIGATION SOFTWARE 1.0 (Lot serial: ); Model Catalog: 22201F::KOLIBRI NAVIGATION SW ENT 2.7 (Lot serial: ); Model Catalog: 71072::UPD KOLIBRI NAV SW ENT 2.6 TO 2.7 (Lot serial: ); Model Catalog: 71015::UPGRADE VV ENT 7.9 TO UNLIMITED 1.0 (Lot serial: ); Model Catalog: 71068::UPDATE VV NAV SW ENT 7.8 TO 7.9 (Lot serial: ); Model Catalog: 22076G::VV NAVIGATION SW ENT 7.9 (Lot serial: ); Model Catalog: 22207::CRANIAL ESSENTIAL NAV SW 1.0 (Lot serial: ); Model Catalog: 22208::CRANIAL UNLIMITED NAV SW 1.0 (Lot serial: ); Model Catalog: 22204E::KOLIBRI NAVIGATION SW CRANIAL 2.7 (Lot serial: ); Model Catalog: 71077::UPG CRA UNL 1.0 FROM VV CRA 7.X (Lot serial: ); Model Catalog: 71012::UPGRADE VV CRANIAL 7.9 TO UNLIMITED 1.0 (Lot serial: ); Model Catalog: 71067::UPDATE VV NAV SW CRANIAL 7.8 TO 7.9 (Lot serial: ); Model Catalog: 71011::UPG CRA ESSENTIAL 1.0 TO UNLIMITED 1.0 (Lot serial: ); Model Catalog: 2
  • Descripción del producto
    KOLIBRI ENT 2.7/ENT ESSENTIAL 1.0/ENT UNLIMITED 1.0 NAVIGATION SOFTWARE
  • Manufacturer
    BRAINLAB AG

Manufacturer

BRAINLAB AG
  • Dirección del fabricante
    MUNICH
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    HC