Events

Recall of NAVIGATION SOFTWARE CRANIAL

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
    140293
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-25
  • 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
    The following may have a significant effect on the overall navigation accuracy: -large distance between reference array and region of interest.-major changes of the camera position relative to the reference array during the procedure.

Device

NAVIGATION SOFTWARE CRANIAL
  • Model / Serial
    Model Catalog: 71011::UPG CRA ESSENTIAL 1.0 TO UNLIMITED 1.0 (Lot serial: N/A); Model Catalog: 71012::UPGRADE VV CRANIAL 7.9 TO UNLIMITED 1.0 (Lot serial: N/A); Model Catalog: 22208::CRANIAL UNLIMITED NAV SW 1.0 (Lot serial: N/A); Model Catalog: 22207::CRANIAL ESSENTIAL NAV SW 1.0 (Lot serial: N/A); Model Catalog: 71006 (Lot serial: N/A); Model Catalog: 71067::UPDATE VV NAV SW CRANIAL 7.8 TO 7.9 (Lot serial: N/A); Model Catalog: 71077::UPG CRA UNL 1.0 FROM VV CRA 7.X (Lot serial: N/A); Model Catalog: 71000 (Lot serial: N/A); Model Catalog: 71008 (Lot serial: N/A); Model Catalog: 71017 (Lot serial: N/A); Model Catalog: 71051 (Lot serial: N/A); Model Catalog: 71053 (Lot serial: N/A); Model Catalog: 71056 (Lot serial: N/A); Model Catalog: 22040(V4.0) (Lot serial: N/A); Model Catalog: 22040(7.8) (Lot serial: N/A); Model Catalog: 22040(7.7) (Lot serial: N/A); Model Catalog: 22040(7.9) (Lot serial: N/A); Model Catalog: 22040G::VV NAVIGATION SW CRANIAL 7.9 (Lot serial: N/A)
  • Product Description
    Brainlab Cranial Navigation System
  • Manufacturer
    BRAINLAB AG

Manufacturer

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