Draeger Medical, Inc.: Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 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

Recall number

Z-2250-2018

Recalling firm

Draeger Medical, Inc.

Product

Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 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

Status

Terminated

Initiated

2018-05-24

Posted

not on file

Terminated

2020-05-12

Reason

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.

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

62

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.

Lot, serial or model codes

ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218

510(k) numbers

["K042419"]

PMA numbers

not on file

Product code

BSZ

Firm FEI

2517967

Firm city

Telford

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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