{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "164868", "product_res_number": "Z-2250-2018", "event_date_initiated": "2018-05-24", "event_date_created": "2018-06-19", "recall_status": "Terminated", "event_date_terminated": "2020-05-12", "res_event_number": "80209", "product_code": "BSZ", "k_numbers": [ "K042419" ], "product_description": "Fabius GS Premium Anesthesia Machine; Cat. no. 8607000\n\nProduct Usage:\nInhalation 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", "code_info": "ASKM-0102\tASKM-0220 ASKM-0103\tASKM-0221 ASKM-0124\tASKM-0222 ASKM-0125\tASKM-0223 ASKM-0129\tASKM-0224 ASKM-0132\tASKM-0229 ASKM-0133\tASKN-0061 ASKM-0134\tASKN-0090 ASKM-0135\tASLA-0035 ASKM-0136\tASLA-0046 ASKM-0137\tASLA-0047 ASKM-0138\tASLA-0048 ASKM-0139\tASLA-0049 ASKM-0189\tASLA-0050 ASKM-0190\tASLA-0053 ASKM-0191\tASLA-0070 ASKM-0192\tASLA-0071 ASKM-0193\tASLA-0072 ASKM-0194\tASLA-0073 ASKM-0195\tASLA-0074 ASKM-0198\tASLA-0075 ASKM-0199\tASLA-0129 ASKM-0200\tASLA-0131 ASKM-0201\tASLA-0133 ASKM-0202\tASLA-0140 ASKM-0204\tASLA-0141 ASKM-0205\tASLA-0159 ASKM-0207\tASLA-0199 ASKM-0208\tASLA-0200 ASKM-0215\tASLA-0201 ASKM-0219\tASLA-0218", "firm_fei_number": "2517967", "recalling_firm": "Draeger Medical, Inc.", "address_1": "3135 Quarry Rd", "city": "Telford", "state": "PA", "postal_code": "18969-1042", "additional_info_contact": "DraegerService Technical Support\n800-437-2437", "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\nin a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.", "root_cause_description": "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\n\nIn addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information.\n\nIf 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).", "product_quantity": "62", "distribution_pattern": "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.", "openfda": { "k_number": [ "K112722", "K981845", "K923172", "K983635", "K171292", "K791530", "K092864", "K864806", "K000859", "K930492", "K973971", "K923519", "K061609", "K884879", "K864590", "K133886", "K022031", "K102182", "K080175", "K062155", "K771989", "K041622", "K101439", "K081941", "K071097", "K102471", "K864589", "K120075", "K253330", "K844849", "K071142", "K122063", "K901713", "K894309", "K800801", "K830161", "K850648", "K844563", "K862831", "K945463", "K251352", "K841274", "K000706", "K862085", "K151954", "K853139", "K971425", "K982137", "K833335", "K131945", "K934669", "K760228", "K133958", "K803052", "K973949", "K855022", "K920944", "K930351", "K946127", "K884991", "K112114", "K801100", "K081447", "K050626", "K050055", "K852175", "K905635", "K854213", "K061102", "K110213", "K900937", "K973985", "K771479", "K042419", "K853435", "K980553", "K142552", "K864447", "K171311", "K033026", "K073707", "K945234", "K882489", "K965160", "K830160", "K901117", "K123125", "K861170", "K050676", "K771057", "K833147", "K050883", "K963481", "K890410", "K030624", "K851621", "K090892", "K000995", "K872178", "K131790", "K040743", "K935546", "K042086", "K032803", "K884802", "K132903", "K030939", "K172045", "K972848", "K123211", "K901119", "K143530", "K122445", "K042607", "K981530", "K003663", "K151570", "K863207", "K191027", "K001727", "K230931", "K864644", "K893780", "K001315", "K900329", "K921742", "K081844", "K970163", "K801103", "K003251", "K974193", "K213867", "K844008", "K090233", "K992421", "K011404", "K083098", "K170872", "K132530", "K963994", "K933285", "K830159", "K993410", "K001488", "K160665", "K913791", "K060193", "K802591", "K965041", "K062388", "K031400", "K072884", "K841370", "K844421", "K790456", "K042154", "K875350", "K103035", "K945722", "K003579", "K033498", "K113633", "K252746", "K051629", "K903991", "K083413", "K902962", "K840356", "K102389", "K844012", "K925580", "K001988", "K201957", "K052335", "K010613", "K041430", "K822218", "K072420", "K830680", "K903135", "K012446", "K971030", "K770554", "K833151", "K801102", "K900328", "K973896", "K781492", "K140264" ], "registration_number": [ "1054713", "3014579161", "3007603826", "3005783425", "9610531", "3007238566", "1066427", "3013188547", "9617604", "3021559257", "3049808762", "9710602", "2112667", "2221819", "3010703925", "3022543477", "2518157", "3003589956", "3035111606", "8043316", "1000122786", "1066270", "9611500", "2020813", "8010042", "3009156722", "9611295", "3000126629", "3009129579", "3016618143", "3005803793", "3010157426", "1530958" ], "fei_number": [ "1000639866", "3014579161", "3007603826", "3005783425", "3002558692", "3007238566", "3002808128", "3013188547", "3002807907", "3007513035", "3021559257", "3049808762", "2112667", "2221819", "3010703925", "3022543477", "2518157", "3003513129", "3003589956", "3035111606", "1000122786", "3002807992", "2020813", "3009156722", "3000126629", "3009129579", "3001104093", "3016618143", "3005803793", "3010157426", "1000114111", "3000957797", "3003319165" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }