{ "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": "138314", "product_res_number": "Z-2271-2015", "event_date_initiated": "2015-06-22", "event_date_posted": "2015-07-27", "recall_status": "Terminated", "event_date_terminated": "2017-05-05", "res_event_number": "71592", "product_code": "BSZ", "k_numbers": [ "K072884" ], "product_description": "Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.", "code_info": "Catalog Number(s): 8607300", "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": "Customer Support\n215-721-5400", "reason_for_recall": "the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.", "root_cause_description": "Labeling False and Misleading", "action": "Draeger Medical sent an Urgent Medical Device Recall Letter, dated June 2015, and Instructions for Use Supplement (one supplement for each Fabius MRI Anesthesia Machine at the facility) to end users. The letter identified the affected product, problem and actions to be taken. For questions regarding the recall letter contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of the Drger Fabius MRI anesthesia machine contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).", "product_quantity": "373", "distribution_pattern": "US Nationwide Distribution", "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" } } ] }