Recall Z-0501-2022— Draeger Medical, Inc.

Name: FDA recall Z-0501-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-16

Class II · Terminated

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2021-12-16, terminated 2023-04-17. It names one FDA 510(k) clearance: K072884. Product: Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300. 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..

Recalling firm: Draeger Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-16
Terminated: 2023-04-17
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072884 — FABIUS MRIDraeger Medical AG & Co. KG·cleared 2008-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.