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Draeger Medical, Inc. Recall 89243

Description: Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Draeger Medical, Inc. Recall 89243 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0501-2022
Event ID89243
Event DescriptionDraeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Product TypeDevices
DistributionUS Nationwide distribution in the states of NY, PA, and WI.
Recall Reason26 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 Classification20220126
Device Code InfoUDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
Center Classification Date20220114
Recall Initiation Date20211216
Recalling FirmDraeger Medical, Inc.
Initial Notification Letter
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