Dräger Medical is recalling its Fabius Anesthesia machines because they may have excessive oil that was not removed during production of the machines. This oil may interfere with the position detector of the ventilation motor during operation and cause the ventilation to fail, which can lead to serious patient injury or death.
The recall affects several lots of Fabius Anesthesia machines including Fabius GS Premium, Fabius Tiro, Fabius Tiro M, and Fabius MRI. A total of 62 machines are being recalled from the following states: 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.
Fabius Anesthesia machines are inhalation devices that are used in operating, induction, and recovery rooms at hospitals and at Magnetic Resonance Imaging (MRI) settings with patients of all ages. They are used with either oxygen, nitrous oxide, or air supplied by a medical gas pipeline system or by externally mounted gas cylinders.
Dräger Medical informed medical facilities with affected units about the recall, and that they could continue using 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.
Any adverse events or quality issues related to affected Fabius Anesthesia machines should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice