Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
This recall has been terminated (originally issued July 27, 2015).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- June 22, 2015
- Posted
- July 27, 2015
- Terminated
- May 5, 2017
- Recall Number
- Z-2271-2015
- Quantity
- 373
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution
Lot / Code Info
Catalog Number(s): 8607300
Root Cause
Labeling False and Misleading
Action Taken
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).