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Fabius MRI 8607300

by Drägerwerk AG & Co. KGaA

Ref 8607300Model 041498

Fabius MRI 8607300 is a device classified as Class IIb in the EU and Class II in the US made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-04048675041498), cleared under FDA 510(k) K072884 on 30 Jul 2008 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04048675041498), active as of 12 Nov 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K072884

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04048675041498 Basic UDI-DI 04048675041498UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675041498 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK072884 Date30 Jul 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04048675041498 registered 27 May 2026 Active
  • FDA 510(k) K072884 decided 30 Jul 2008 Active
  • FDA GUDID UDI-DI 04048675041498 listed 24 Oct 2015 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0501-2022 FDA Class II initiated 16 Dec 2021

    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, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

    • Terminated Z-2252-2018 FDA Class II initiated 24 May 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 the patient. Potential adverse outcomes include death of the patient.

    • Terminated Z-1481-2018 FDA Class I initiated 1 Mar 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.

    • Terminated Z-2271-2015 FDA Class II initiated 22 Jun 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 of the MRI.

Timeline

7 dated events

  1. Cleared FDA 510(k) K072884
  2. Recall initiated FDA recalls Z-2271-2015
  3. Listed FDA GUDID 04048675041498
  4. Recall initiated FDA recalls Z-1481-2018
  5. Recall initiated FDA recalls Z-2252-2018
  6. Recall initiated FDA recalls Z-0501-2022
  7. Registered EUDAMED B-04048675041498

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Fabius MRI
Generic name
Anaesthesia workstation, general-purpose
Model / reference
8607300, 041498
Primary DI / UDI-DI
04048675041498
Basic UDI-DI
B-04048675041498
FDA product code
BSZ
EMDN code
Z1203010101 Anaesthesia devices
GMDN term
Anaesthesia workstation, general-purpose
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5160
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Anaesthesia workstation, general-purpose

Similar devices in this category

Other devices filed under ANAESTHESIA DEVICES.

Other devices from Drägerwerk AG & Co. KGaA

See all devices from Drägerwerk AG & Co. KGaA →

Properties

  • Administering medicine
  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)