Draeger Fabius MRI Anesthesia Machine — Class II medical device recall Z-0501-2022
Terminated recall by Draeger Medical, Inc., reported 2022-01-26, distributed nationwide. 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and
| Recall number | Z-0501-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2021-12-16 |
| Classified | 2022-01-14 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2023-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| UPC / GTIN / UDI-DI | 04048675041498 |
| Serial numbers | ASPJ-0019, ASPJ-0020, ASPJ-0021, ASPK-0001, ASPK-0002 |
| Model numbers | 8607300 |
Product
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0501-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.