The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product(s): Fabius GS Premium, Fabius Tiro, Fabius Tiro M, Fabius MRI Anesthesia Machines
- Model/Item Numbers: See complete lists for Fabius GS Premium, Fabius Tiro, Fabius Tiro M, Fabius MRI Anesthesia Machines
- Manufacturing Dates: June 1, 2017 to November 30, 2017
- Distribution Dates: July 14 2017 to December 13 2017
Devices Recalled in the U.S.: 62 units in Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and Puerto Rico.
The Fabius Anesthesia machines are inhalation anesthesia machines for use in operating, induction and recovery rooms at hospitals and at Magnetic Resonance Imaging (MRI) settings with patients of all ages. They may be used with oxygen (O2), nitrous oxide (N2O), and air supplied by a medical gas pipeline system or by externally mounted gas cylinders.
Reason for Recall
Dräger Medical is recalling the Fabius Anesthesia machines due to excessive oil that was not removed at the time of production. Such excess oil may interfere with the position detector of the ventilation motor during operation and may cause ventilation to fail. A halt in ventilation may lead to serious adverse health consequences, including patient injury or death.
Who May be Affected
- All patient groups who may be given anesthesia and breathing support using these devices
- Health care providers using Fabius Anesthesia Machines
What to Do
Dräger Medical sent an Urgent Medial Device Recall notification letter on March 1, 2018, instructing customers to continue to operate the devices with the usual attention and to ensure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use.
The company is producing replacement motors and a service representative will contact affected customers to arrange appointments for replacing the motor free of charge.
Customers who want more information about the March 1, 2018, Urgent Medial Device Recall notification letter may call Dräger Medical from 8:00 am to 4:30 pm Eastern Standard Time at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and servicing of the Fabius Anesthesia machines, please contact the Dräger Service Technical Support between the hours of 8:00 am to 8:00 pm Eastern Standard Time at 1-800-437-2437 (press 4 at the prompt then 4 again).
Date Recall Initiated
March 1, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.