Events

Recall of NAVIGATION SOFTWARE ENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BRAINLAB AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    107383
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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
  • Product Description
    KOLIBRI ENT 2.7/ENT ESSENTIAL 1.0/ENT UNLIMITED 1.0 NAVIGATION SOFTWARE
  • Manufacturer
    BRAINLAB AG

Manufacturer

BRAINLAB AG
  • Manufacturer Address
    MUNICH
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    HC