FDA Device recall Z-0501-2022
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
- FDA Device
- Class II
- terminated
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 by Draeger Medical, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0501-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-16 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Reason
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.
Identifiers
| code_info | UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2022%22
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