Use cautionMedical device recall · FDA · Published December 16, 2021
Draeger Fabius MRI Anesthesia Machine Oxygen Flow Issue Recall
Draeger recalls 26 Fabius MRI Anesthesia Machines with oxygen flow control error that may cause patient oxygenation issues if central oxygen pressure is unstable.
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
Take action
Contact the company
📍Recalling firmDraeger Medical, Inc.3135 Quarry Rd · Telford, PA 18969-1042
“Draeger Fabius MRI Anesthesia Machine Oxygen Flow Issue Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61423-draeger-fabius-mri-anesthesia-machine-oxygen-flow-issue-recall. Based on FDA recall #Z-0501-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2022%22&limit=1).
The FDA announced on 2021-12-16 that Draeger Medical, Inc. is recalling the Draeger Fabius MRI Anesthesia Machine due to a hazard of insufficient patient oxygenation. The recall affects units with catalog number 8607300 distributed nationwide in New York, Pennsylvania, and Wisconsin.
How to tell if you have it
Brand: Draeger
Product: Fabius MRI Anesthesia Machine
Catalog Number: 8607300
Serial Numbers: ASPJ-0019, ASPJ-0020, ASPJ-0021, ASPK-0001, ASPK-0002
The hazard
The affected machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If hospital O2 central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value, potentially causing insufficient oxygenation of the patient.
Context
GovInfoNow's records show Draeger Medical, Inc. has 16 other recalls on record since 2018-03-01. Recent brand recalls include the 2024-10-15 recall of the Atlan A300 and Atlan A350 Anesthesia Workstations for risk of ventilator failure, and the 2024-03-20 recall of the Draeger Perseus A5 for battery shutdown risk during anesthesia use. Other recent recalls of similar products include the 2026-05-07 recall of the Draeger Atlan A350 Anesthesia Workstation for risk of ventilator failure and the 2026-06-24 recall of Maquet Flow-i Anesthesia Machines for inadequate anesthesia delivery.
How to tell if you have this one
Check for the specific serial numbers: ASPJ-0019, ASPJ-0020, ASPJ-0021, ASPK-0001, ASPK-0002. The machine has Catalog Number 8607300 and UDI 04048675041498.
Brand
Draeger
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Machine Details
Verify the serial numbers and catalog number to confirm if your machine is in the recall list.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NY, PA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New York, Pennsylvania, Wisconsin.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0501-2022 (December 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0501-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.