Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk
Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric. The hazard involves the failure of a critical life-support function (ventilation) in a medical device.
Plain-English summary
Draeger Medical, Inc. is recalling one unit of the Fabius Tiro M anesthesia machine, catalog number 8608400, serial number ASKK-0001. The product is an inhalation anesthesia machine used in operating, induction, and recovery rooms. It is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure, volume, and inspiratory oxygen concentration.
The recall is being issued because the automatic ventilation may fail if the position detection of the motor is disturbed. Additionally, if the ventilator cover is damaged, manual ventilation may also fail.
The affected unit was 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. Users should contact Draeger Medical, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Fabius Tiro M, anesthesia machine, catalog no. 8608400 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…
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial no. ASKK-0001
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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