Fabius MRI Anesthesia Machine recallZ-2271-2015 · Draeger Medical, Inc. · initiated Jun 22, 2015
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling False and Misleading
What the company is doing
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).
Recall details
- Recall number
- Z-2271-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 22, 2015
- Posted by the FDA
- Jul 27, 2015
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 373
- Product code
- BSZ
- FDA submissions
- K072884
- Distribution
- US Nationwide Distribution
Product description
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Code information (models, lots, serial numbers)
Catalog Number(s): 8607300
Other devices under the same FDA submission
1 device cleared under K072884 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fabius MRI 8607300Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia1 recall19 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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