FDA recall Z-0501-2022

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-12-16

Report date

2022-01-26

Termination date

2023-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2022