FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
- Recall number
- Z-2271-2015
- Recalling firm
- Draeger Medical, Inc.
- Product
- Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
- Status
- Terminated
- Initiated
- 2015-06-22
- Posted
- 2015-07-27
- Terminated
- 2017-05-05
- Reason
- 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
- 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
- 373
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Catalog Number(s): 8607300
- 510(k) numbers
- ["K072884"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28