CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
Draeger Fabius MRI Anesthesia Machine recalled by Draeger Medical
Draeger Medical is recalling Draeger Fabius MRI Anesthesia Machine, distributed nationwide in the US. The recall was initiated on 16 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0501-2022
- FDA event ID
- 89243
- Recalling firm
- Draeger Medical, Telford, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2021
- FDA classified
- 14 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Imaging Equipment
Timeline
| 16 Dec 2021 | Recall initiated by company | |
| 14 Jan 2022 | Classified by FDA | +29 days |
| 26 Jan 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Where it was distributed
US Nationwide distribution in the states of NY, PA, and WI.
Questions about this recall
Is Draeger Fabius MRI Anesthesia Machine recalled?
Yes. Draeger Medical recalled Draeger Fabius MRI Anesthesia Machine on 16 Dec 2021. The recall is Class II and its status is Terminated. Recall number Z-0501-2022.
Why was it recalled?
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.
Which lots are affected?
UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
Where was it sold?
US Nationwide distribution in the states of NY, PA, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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