Events

Recall of SPY INTRA-OPERATIVE IMAGING SYSTEM

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

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
    106893
  • Event Risk Class
    I
  • Event Initiated Date
    2004-05-06
  • 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
    Novadaq became aware of a potentially serious fault in the mechanical arm. it was resolved that novadaq should undertake a field replacement of all arms on the spy200o model and upgrade/destroy spy1000 devices.

Device

SPY INTRA-OPERATIVE IMAGING SYSTEM
  • Model / Serial
    Model Catalog: SP2000 (Lot serial: N/A); Model Catalog: SP1000 (Lot serial: N/A)
  • Product Description
    SPY INTRAOPERATIVE IMAGING SYSTEM
  • Manufacturer
    NOVADAQ TECHNOLOGIES INC.

Manufacturer

NOVADAQ TECHNOLOGIES INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC