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Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Recalled January 26, 2022 · FDA recall Z-0501-2022 · Draeger Medical
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. · FDA Class II
Units
5
Sold at
US Nationwide distribution in the states of NY, PA, and WI.
Description
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.
Product
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Manufacturer(s)
Draeger Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →