Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a critical life-support device (anesthesia machine) where failure of ventilation could result in serious injury or death, meeting the criteria for a Severe rating due to significant injury risk.
Plain-English summary
Draeger Medical, Inc. is recalling 26 units of the Fabius Tiro anesthesia machine, catalog number 8606000. These devices are inhalation anesthesia machines used in operating, induction, and recovery rooms. They are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure, volume, and inspiratory oxygen concentration.
The recall is due to a potential failure in the automatic ventilation system. This failure may occur if the position detection of the motor is disturbed. Additionally, if the ventilator cover is damaged, manual ventilation may also fail.
The affected units were distributed nationwide to accounts in 21 states (AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI) and Puerto Rico. Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice and contact Draeger Medical for instructions on corrective action.
The recalled product
- Product
- Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted ga
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 26
Distribution
Part of a larger recall action
This product is one of 4 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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