Z-2271-2015Class II

Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in...

Name: Z-2271-2015 Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in...
Creator: Draeger Medical, Inc.
Published: 2015-06-22
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2015-06-22 / Terminated / root cause: labeling and UDI

FDA source

Draeger Medical, Inc. began a recall of Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms on 2015-06-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2271-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-22
Posted: 2015-07-27
Terminated: 2017-05-05
Recalling firm: Draeger, Inc.
Product: Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Draeger Medical sent an Urgent Medical Device Recall Letter, dated June 2015, and Instructions for Use Supplement (one supplement for each Fabius MRI Anesthesia Machine at the facility) to end users. The letter identified the affected product, problem and actions to be taken. For questions regarding the recall letter contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of the Drger Fabius MRI anesthesia machine contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Quantity in commerce: 373
Distribution: US Nationwide Distribution
Product codes and lots: Catalog Number(s): 8607300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2271-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2271-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-27

Product code BSZ

K072884Class IIFabius MRIDraeger Medical AG & Co. KG / cleared 2008-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)