Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling 27 Fabius GS Premium 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 source text explicitly identifies the agency classification as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Draeger Medical, Inc. is recalling 27 units of the Fabius GS Premium anesthesia machine, catalog number 8607000. These devices are used in operating, induction, and recovery rooms for inhalation anesthesia and are equipped with electrically driven ventilators and monitors for airway pressure, volume, and oxygen concentration.
The recall was initiated because the automatic ventilation function may fail if the position detection of the motor is disturbed. Additionally, if the ventilator cover is damaged, manual ventilation may also fail. The agency has classified this as a Class I recall.
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. Users should check their device serial numbers against the list provided by the manufacturer and contact Draeger Medical for instructions on repair or replacement.
The recalled product
- Product
- Fabius GS Premium, anesthesia machine, catalog no. 8607000 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 moun
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 27
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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