Model note · Anaesthesia Machine
Draeger Fabius GS and Fabius GS Premium
The Fabius family are Draeger continuous flow anaesthesia machines. They cover spontaneous, manual, automatic and pressure support ventilation, and monitor inspired O2, airway pressure and volume. They were first cleared in 2002. A 2004 software change added apnea ventilation inside pressure support. The S-ORC module is the hypoxic guard that stops N2O being set without enough O2. In 2018 a fault meant some GS Premium units could deliver 100% N2O. Other recalls cover casters breaking off, power supply clearance, the APL valve knob, MRI attraction and swapped internal O2 hoses on the MRI model.
The model
Maker, model and type.
- Maker
- Draeger Medical, Inc. / Draegerwerk AG & Co. KGaA
- Model
- Fabius GS and Fabius GS Premium (with Fabius Tiro, Fabius OS and Fabius MRI variants)
- Device type
- Anaesthesia Machine
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | Gas machine for anaesthesia, 21 CFR 868.5160, Class II, product code BSZ; Fabius GS K011404 (2002), K041622 and K042086 (2004, apnea ventilation), Fabius Tiro K031400 (2003), Fabius MRI K072884 (2008) | Source |
| Ventilation | Spontaneous, manually assisted, automatic and pressure support ventilation during anaesthesia | Source |
| Monitoring | Inspired oxygen concentration, breathing pressure and respiratory volume | Source |
| Apnea ventilation (pressure support) | If spontaneous rate falls below the Freq Min setting, a pressure support breath is delivered at the preset settings; the machine stays in pressure support; user can disable it | Source |
| Catalogue numbers in recalls | Fabius GS 8604699, Fabius GS Premium 8607000, Fabius MRI 8607300 | Source |
Recalls
Known FDA recalls.
- Z-0501-20222021-12-16
Fabius MRI: internal O2 hoses to flush and flow control interchanged.
FDA record - Z-2250-20182018-05-24
Fabius GS Premium: S-ORC fault could allow a hypoxic N2O mixture (62 units).
FDA record - Z-1481-20182018-03-01
Fabius MRI: automatic, and possibly manual, ventilation could fail.
FDA record - Z-2271-20152015-06-22
Fabius MRI parts attracted by the scanner magnetic field.
FDA record - Z-0008-20142013-08-14
Power supply clearance and high voltage test failures (1,127 units).
FDA record - Z-1315-20082008-02-05
Caster may break loose from an out of spec chassis.
FDA record
Safety
Safety warnings from the record.
- With the 2018 S-ORC fault, some Fabius GS Premium units could deliver 100% N2O, a hypoxic mixture that can kill the patient. Source
- A Fabius MRI placed too close to the scanner can have parts loosened or pulled by the magnetic field. Source
- Swapped O2 hoses on the MRI model let fresh gas O2 drift with central supply pressure, with risk of under oxygenation if not noticed. Source
Sources
Where this note comes from.
- FDA 510(k) K042086 summary, Fabius GS and Fabius Tiro (apnea ventilation)
- openFDA 510(k) records for Fabius
- openFDA device recall records for Fabius
- openFDA MAUDE problem counts for the Fabius GS
Not covered: The Fabius instructions for use and technical documentation were not read, so ventilator setting ranges, battery back up time, the S-ORC ratio and the daily check procedure are not included. The S-ORC test in the first checks is general hypoxic guard practice, not a quoted Draeger procedure.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Anaesthesia Machine
Other models of this device.
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