Events

Recall of FABIUS GS ANESTHESIA SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA 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
    49912
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-26
  • 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 fabius gs or fabius tiro delivered between june 2005 and june 2006 could have been equipped with a power cord of the manufacturer electri-cord manufacturing corporation (ecm). the us food and drug administration (fda) has associated a risk of sparks fire device failures or electrical shocks with these power cords. although drager medical has not received any reports of failures of power cords manufactured by ecm drager medical will replace the possible affected power cords.

Device

FABIUS GS ANESTHESIA SYSTEM
  • Model / Serial
    Model Catalog: 8604700 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Description
    FABIUS GS ANESTHESIA SYSTEM
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.