Draeger Medical, Inc. Recall 89243
Description: Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Draeger Medical, Inc. Recall 89243 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0501-2022 |
| Event ID | 89243 |
| Event Description | Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NY, PA, and WI. |
| Quantity | 5 |
| Recall 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. |
| Device Classification | 20220126 |
| Device Code Info | UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002 |
| Center Classification Date | 20220114 |
| Recall Initiation Date | 20211216 |
| Recalling Firm | Draeger Medical, Inc. |
| Initial Notification | Letter |
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