Z-0501-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- December 16, 2021
- Termination Date
- April 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
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.
Distribution Pattern
US Nationwide distribution in the states of NY, PA, and WI.
Code Information
UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002