Events

Recall of Drager Fabius MRI Anaesthesia Machine

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical Australia Pty Ltd.

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
    RC-2015-RN-00535-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00535-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Drager became aware of cases in which the fabius mri or parts of the system were attracted by the magnetic field of the mri. if the fabius mri is positioned too close to the mri, the magnetic force of the mri can loosen parts of the fabius mri and cause personal injury.
  • Action
    Drager Medical is updating the Instructions for Use Manual and the device labelling clearly state that the device must only be used in areas where the field intensity is no more than 40 mTesla. Additionally, the ventilator door will be altered to include another lock in addition to the existing locking mechanism. This action has been closed-out on 15/08/2016.

Device

Drager Fabius MRI Anaesthesia Machine

Manufacturer

Draeger Medical Australia Pty Ltd