Drug recall
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
FDA recall event 89243 · Class II · Draeger Medical, Inc.
Key facts
| Event ID | 89243 |
|---|---|
| Recall numbers | Z-0501-2022 |
| Recalling firm | Draeger Medical, Inc. |
| Product type | Devices |
| Products | Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 16, 2021 |
| Report date | Jan 26, 2022 |
| Termination date | Apr 17, 2023 |
| City | Telford |
| State | PA |
| Country | United States |
| FEI number | 2517967 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: