Draeger Fabius MRI Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling eight Fabius MRI anesthesia machines because automatic or manual ventilation may fail if the motor position is disturbed or the ventilator cover is damaged.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (ventilation failure) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Draeger Medical, Inc. is recalling eight Fabius MRI anesthesia machines, catalog number 8607300. These devices are inhalation anesthesia machines used in operating, induction, and recovery rooms, and are equipped with an electrically driven ventilator and monitors for airway pressure, volume, and oxygen concentration. The machines are designed for use with medical gas pipelines or externally mounted gas cylinders and can be used in MRI scanner rooms with specific magnetic field strengths.
The recall is due to a potential failure in the automatic ventilation system 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 the affected units by checking the serial numbers: ASKM-0020, ASKM-0011, ASKL-0005, ASKL-0007, ASKL-0010, ASKM-0031, ASKM-0032, and ASKM-0023. Users should contact Draeger Medical for instructions on how to address the defect.
The recalled product
- Product
- Fabius MRI, anesthesia machine, catalog no. 8607300 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 gas
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- Affected units
- 8
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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