Events

Recall of FABIUS TIRO 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
    47692
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-08
  • 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
    Some units did not pass the high voltage final test during the final checking of the fabius in draeger production facility. investigations carried out revealed that on some power supply units from a particular batch the required minimum clearance bewteen an electrical component and the unit housing was not maintained. under the influence of mechanical forces (eg. movement of the device) this may result in small bypass currents flowing in the interior of the unit which in extreme cases cause failure of the automatic ventilation function of the device. when such faults occur the standard required manual ventilation is possible an acoustic alarm is generated and the indicators on the device flash.

Device

FABIUS TIRO ANESTHESIA SYSTEM
  • Model / Serial
    Model Catalog: 8606000 (Lot serial: >10 numbers contact mfg); Model Catalog: 8607000 (Lot serial: >10 numbers contact mfg)
  • Product Description
    FABIUS TIRO
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.