Food, drugs, devices › Draeger Medical, Inc.
Device recall: Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
FDA enforcement event 89243 is a device recall by Draeger Medical, Inc. of Telford, PA, initiated 16 Dec 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 17 Apr 2023. Initiation: voluntary: firm initiated. Draeger Medical, Inc. has 30 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Draeger Medical, Inc., Telford, PA.
Reason for recall
"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."
Distribution
"US Nationwide distribution in the states of NY, PA, and WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0501-2022 | Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 | 5 | Class II | Terminated | 26 Jan 2022 |
Context
Other enforcement events for Draeger Medical, Inc.
All 30 events for Draeger Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of NY, PA, and WI."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Apr 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.