Z-1481-2018Class I

Fabius MRI, anesthesia machine, catalog no. 8607300

Name: Z-1481-2018 Fabius MRI, anesthesia machine, catalog no. 8607300
Creator: Draeger Medical, Inc.
Published: 2018-03-01
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2018-03-01 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery... on 2018-03-01. FDA classified it as Class I and gives the reason as "The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail". 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-1481-2018
Classification: Class I
Status: Terminated
Initiated: 2018-03-01
Posted: 2018-05-08
Terminated: 2019-04-16
Recalling firm: Draeger, Inc.
Product: Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter were directed to call Michael Kelhart between 8AM-4:30PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). Questions regarding the operation and/or servicing of the Draeger Fabius anesthesia machine were directed to DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
Quantity in commerce: 8
Distribution: US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
Product codes and lots: Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-0023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1481-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1481-2018	Class I	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07
Z-1482-2018	Class I	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07
Z-1483-2018	Class I	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07
Z-1484-2018	Class I	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)