Z-2252-2018Class II

Fabius GS MRI Anesthesia Machine; Cat. no. 8607300

Name: Z-2252-2018 Fabius GS MRI Anesthesia Machine; Cat. no. 8607300
Creator: Draeger Medical, Inc.
Published: 2018-05-24
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2018-05-24 / Terminated

FDA source

Draeger Medical, Inc. began a recall of Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may... on 2018-05-24. FDA classified it as Class II and gives the reason as "The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2252-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-06-19
Terminated: 2020-05-12
Recalling firm: Draeger, Inc.
Product: Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: 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 machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing 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). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Drger Vapor anesthetic vaporizer. Fabius MRI 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 Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
FDA root cause: Process change control
Action: On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information. If you have any questions regarding this recall 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). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact 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: 4
Distribution: US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
Product codes and lots: ASLA-0017 ASLA-0018 ASLA-0019 ASLA-0020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-19
Z-2251-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-19
Z-2252-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-19
Z-2253-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-19
Z-2254-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-19

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)