Events

Recall of STRYKER NAVIGATION SYSTEM - INTELLECT CRANIAL SOFTWARE

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

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
    23259
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-30
  • 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
    When the user imports two or more image series and changes the viewing direction for both image series there is a potential that the orientation of the second image series is not stored correctly by the system. this could result in two different discrepancies: 1) the automatic correlation algorithm may not achieve a good correlation result and 2) the second image series may be shown with the wrong orientation.

Device

STRYKER NAVIGATION SYSTEM - INTELLECT CRANIAL SOFTWARE
  • Model / Serial
    Model Catalog: 6000-651-200 (Lot serial: 3031); Model Catalog: 6000-652-000 (Lot serial: 3031); Model Catalog: 6000-650-000 (Lot serial: 3001); Model Catalog: 6000-651-000 (Lot serial: 3031); Model Catalog: 6000-650-100 (Lot serial: 3031); Model Catalog: 6000-650-000 (Lot serial: 3031); Model Catalog: 6000-651-200 (Lot serial: 3010); Model Catalog: 6000-652-000 (Lot serial: 3010); Model Catalog: 6000-651-000 (Lot serial: 3010); Model Catalog: 6000-650-100 (Lot serial: 3010); Model Catalog: 6000-650-000 (Lot serial: 3010); Model Catalog: 6000-651-200 (Lot serial: 3004); Model Catalog: 6000-652-000 (Lot serial: 3004); Model Catalog: 6000-651-000 (Lot serial: 3004); Model Catalog: 6000-650-100 (Lot serial: 3004); Model Catalog: 6000-650-000 (Lot serial: 3004); Model Catalog: 6000-651-200 (Lot serial: 3003); Model Catalog: 6000-652-000 (Lot serial: 3003); Model Catalog: 6000-651-000 (Lot serial: 3003); Model Catalog: 6000-650-100 (Lot serial: 3003); Model Catalog: 6000-650-000 (Lot serial: 3003); Model Catalog:
  • Product Description
    STRYKER NAVIGATION SYSTEM - INTELLECT CRANIAL SOFTWARE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC