Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Reported: January 26, 2022 Initiated: December 16, 2021 #Z-0501-2022
Product Description
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.
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 5
- Distribution
- US Nationwide distribution in the states of NY, PA, and WI.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300. Recalled by Draeger Medical, Inc.. Units affected: 5.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0501-2022.
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