# K072884: Fabius Mri

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Jul 30, 2008 after 295 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K901713 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
3 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042419: Fabius GS/Fabius Tiro Anesthesia System, Draeger Medical, Inc. (2004) Summary page 1.
- K050055: GE Datex-Ohmeda Aestiva/5 Mri Anesthesia System, Datex-Ohmeda, Inc. (2005) Summary page 1.

## Recalls of this device
- Dec 16, 2021 · Class II · Z-0501-2022: 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable
- May 24, 2018 · Class II · Z-2252-2018: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to t
- Mar 1, 2018 · Class I · Z-1481-2018: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Jun 22, 2015 · Class II · Z-2271-2015: the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force

## Indications for use
The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume. The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.

Source page: https://510kreport.com/device/K072884
Methodology: https://510kreport.com/methodology