Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating,
FDA device recall Z-2271-2015 · posted 2015-07-27 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- 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.
- 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).
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 373
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-06-22
- Date posted
- 2015-07-27
- Date terminated
- 2017-05-05
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FABIUS MRI (K072884) | Draeger Medical AG & Co. KG | 2008-07-30 |