{ "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": "2026-10-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "163353", "product_res_number": "Z-1481-2018", "event_date_initiated": "2018-03-01", "event_date_posted": "2018-05-08", "recall_status": "Terminated", "event_date_terminated": "2019-04-16", "res_event_number": "79773", "product_code": "BSZ", "k_numbers": [ "K072884" ], "product_description": "Fabius MRI, anesthesia machine, catalog no. 8607300\n\nProduct Usage:\nThe 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.", "code_info": "Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-0023", "firm_fei_number": "2517967", "recalling_firm": "Draeger Medical, Inc.", "address_1": "3135 Quarry Rd", "city": "Telford", "state": "PA", "postal_code": "18969-1042", "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_description": "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.\n\nCustomers 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\nmachine were directed to DraegerService Technical Support between the hours of 8:00 AM \n8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).", "product_quantity": "8", "distribution_pattern": "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.", "openfda": { "k_number": [ "K864589", "K963994", "K781492", "K171311", "K131945", "K801103", "K844563", "K140264", "K083098", "K830161", "K031400", "K132903", "K101439", "K000995", "K112722", "K062155", "K935546", "K863207", "K844849", "K852175", "K000859", "K833151", "K884802", "K901713", "K001988", "K032803", "K974193", "K973971", "K001488", "K850648", "K122445", "K102471", "K033498", "K151954", "K112114", "K771479", "K971030", "K801100", "K000706", "K854213", "K133958", "K033026", "K083413", "K930492", "K894309", "K901117", "K081447", "K081844", "K771057", "K050055", "K980553", "K102389", "K791530", "K945234", "K040743", "K872178", "K052335", "K830159", "K930351", "K042086", "K840356", "K003251", "K853139", "K882489", "K946127", "K981530", "K945463", "K921742", "K050626", "K151570", "K992421", "K010613", "K170872", "K131790", "K973949", "K913791", "K252746", "K113633", "K090892", "K110213", "K855022", "K993410", "K103035", "K965160", "K072884", "K090233", "K864806", "K042419", "K844421", "K945722", "K072420", "K073707", "K051629", "K201957", "K972848", "K123125", "K833147", "K001727", "K801102", "K844008", "K172045", "K802591", "K800801", "K060193", "K844012", "K041622", "K841274", "K884991", "K920944", "K061102", "K923172", "K003663", "K902962", "K864590", "K893780", "K030939", "K983635", "K901119", "K062388", "K970163", "K253330", "K160665", "K102182", "K830160", "K903991", "K973896", "K071097", "K011404", "K042607", "K022031", "K760228", "K191027", "K853435", "K771989", "K132530", "K900329", "K071142", "K770554", "K251352", "K003579", "K122063", "K971425", "K923519", "K171292", "K933285", "K050883", "K061609", "K875350", "K042154", "K934669", "K884879", "K041430", "K900328", "K143530", "K822218", "K230931", "K830680", "K081941", "K973985", "K905635", "K864447", "K133886", "K833335", "K890410", "K900937", "K790456", "K851621", "K803052", "K861170", "K903135", "K092864", "K925580", "K965041", "K123211", "K080175", "K142552", "K981845", "K012446", "K963481", "K213867", "K841370", "K864644", "K862831", "K862085", "K001315", "K120075", "K050676", "K030624", "K982137" ], "registration_number": [ "8010042", "1000122786", "3049808762", "3007603826", "9710602", "1066427", "3005783425", "3000126629", "3010157426", "3022543477", "3013188547", "3003589956", "3021559257", "9611500", "3007238566", "9617604", "2518157", "3009129579", "1054713", "3014579161", "1530958", "1066270", "3035111606", "9611295", "3016618143", "3009156722", "8043316", "3010703925", "3005803793", "9610531", "2221819", "2112667", "2020813" ], "fei_number": [ "1000122786", "3049808762", "3007603826", "3005783425", "3000126629", "3010157426", "3022543477", "3002807992", "3013188547", "3003589956", "3021559257", "3007238566", "2518157", "3009129579", "3003513129", "3014579161", "3035111606", "3016618143", "3009156722", "3010703925", "3000957797", "3002807907", "3007513035", "3005803793", "1000639866", "2221819", "3003319165", "1000114111", "2112667", "3001104093", "3002558692", "3002808128", "2020813" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }