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Recall Observatory FDA recall evidence

Device product

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Z-0501-2022

December 16, 2021

Class II

Product summary

Firm
Draeger Medical, Inc.
Event
Event 89243
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-0501-2022

Official wording

Reason: 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.

Code information: UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002

Distribution pattern: US Nationwide distribution in the states of NY, PA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.