Draeger Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0501-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Product Classification:
Class II
Date Initiated: December 16, 2021
Date Posted: January 26, 2022
Recall Number: Z-0501-2022
Event ID: 89243
Reason for Recall:
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.
Status: Terminated
Product Quantity: 5
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.
Voluntary or Mandated:
Voluntary: Firm initiated