FDA-Device2022-01-26Class II
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Draeger Medical, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of NY, PA, and WI.
Affected count
5
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2022Don't want to check this manually?
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