medical Class II Updated 2022-01-26

Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 860730

Recalled Product

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
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