Z-0501-2022Class II

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Name: Z-0501-2022 Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Creator: Draeger Medical, Inc.
Published: 2021-12-16
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2021-12-16 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 on 2021-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0501-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-16
Posted: 2022-01-14
Terminated: 2023-04-17
Recalling firm: Draeger, Inc.
Product: Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On December 17, 2021, the firm notified customers via Urgent Medical Device Correction Notice. Customers were instructed to do the following: Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Correction Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. A Drger Service representative will contact you to arrange a date for the correction to be performed free of charge. Until the repair has been concluded you may continue using the device under constant supervision as long as appropriate O2-monitoring is in place and a suitable alarm limit is set. Please consider a suitable buffer when adjusting the O2 flow. If you have any questions regarding the operation of your Fabius MRI Anesthesia Machine, please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437- 2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding this recall communication, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Quantity in commerce: 5
Distribution: US Nationwide distribution in the states of NY, PA, and WI.
Product codes and lots: UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0501-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0501-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-26	2022-01-14

Product code BSZ

K072884Class IIFabius MRIDraeger Medical AG & Co. KG / cleared 2008-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)