{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190921", "product_res_number": "Z-0501-2022", "event_date_initiated": "2021-12-16", "event_date_created": "2022-01-14", "recall_status": "Terminated", "event_date_terminated": "2023-04-17", "res_event_number": "89243", "product_code": "BSZ", "k_numbers": [ "K072884" ], "product_description": "Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300", "code_info": "UDI 04048675041498\nSerial Numbers \nASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002", "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": "Michael A. Kelhart\n215-660-2349", "reason_for_recall": "26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.", "root_cause_description": "Process control", "action": "On December 17, 2021, the firm notified customers via Urgent Medical Device Correction Notice. Customers were instructed to do the following:\n\nPlease ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Correction Notice. \n\nIf you have provided the products to third parties, please forward a copy of this information. \n\nPlease keep this information at least until the corrective measure has been completed. \n\nPlease also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information.\n\nA Drger Service representative will contact you to arrange a date for the correction to be performed free of charge.\n\nUntil the repair has been concluded you may continue using the device under constant\nsupervision as long as appropriate O2-monitoring is in place and a suitable alarm limit is set. Please consider a suitable buffer when adjusting the O2 flow.\n\nIf you have any questions regarding the operation of your Fabius MRI Anesthesia Machine, please\ncontact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-\n2437 (press 2 at the prompt, then 2, then 2 again).\n\n\nIf you have any questions regarding this recall communication, please contact Michael Kelhart between the hours of 8:00\nAM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).", "product_quantity": "5", "distribution_pattern": "US Nationwide distribution in the states of NY, PA, and WI.", "openfda": { "k_number": [ "K840356", "K862085", "K033026", "K833335", "K001488", "K042086", "K133886", "K901119", "K862831", "K830680", "K012446", "K142552", "K923172", "K123211", "K893780", "K050883", "K894309", "K935546", "K041430", "K032803", "K122445", "K983635", "K110213", "K973985", "K980553", "K971425", "K151954", "K992421", "K923519", "K120075", "K132903", "K112722", "K903991", "K172045", "K771057", "K841274", "K151570", "K901713", "K030939", "K852175", "K071097", "K855022", "K050626", "K030624", "K830161", "K833151", "K042154", "K965160", "K913791", "K252746", "K771989", "K833147", "K171311", "K801103", "K982137", "K830159", "K123125", "K131790", "K132530", "K920944", "K251352", "K103035", "K000859", "K003251", "K041622", "K875350", "K760228", "K905635", "K844563", "K071142", "K042607", "K160665", "K973896", "K863207", "K902962", "K800801", "K884991", "K102471", "K945722", "K051629", "K981530", "K092864", "K201957", "K113633", "K011404", "K822218", "K900329", "K060193", "K122063", "K801100", "K230931", "K884802", "K090892", "K864590", "K052335", "K010613", "K970163", "K946127", "K972848", "K081844", "K921742", "K903135", "K844012", "K981845", "K973971", "K850648", "K081941", "K040743", "K853139", "K081447", "K191027", "K771479", "K802591", "K062155", "K000706", "K143530", "K861170", "K083098", "K003663", "K965041", "K022031", "K930351", "K050676", "K050055", "K841370", "K791530", "K140264", "K900937", "K003579", "K042419", "K963994", "K072420", "K934669", "K803052", "K864589", "K971030", "K945463", "K844008", "K844849", "K102182", "K781492", "K864806", "K790456", "K933285", "K083413", "K901117", "K900328", "K973949", "K851621", "K131945", "K253330", "K882489", "K073707", "K854213", "K133958", "K170872", "K061102", "K171292", "K801102", "K853435", "K864644", "K033498", "K001727", "K080175", "K000995", "K770554", "K062388", "K101439", "K061609", "K213867", "K072884", "K993410", "K884879", "K945234", "K031400", "K102389", "K872178", "K974193", "K844421", "K890410", "K001315", "K930492", "K963481", "K001988", "K864447", "K112114", "K925580", "K090233", "K830160" ], "registration_number": [ "", "1530958", "2221819", "8010042", "3013188547", "2112667", "3010703925", "2020813", "1000122786", "9611295", "3007238566", "3001104093", "3005783425", "3009156722", "3000126629", "9710602", "9610531", "8043316", "3016618143", "3021559257", "3005803793", "1066427", "1066270", "3003589956", "9617604", "3022543477", "3007603826", "3009129579", "9611500", "2518157", "3010157426", "1054713", "3014579161", "3035111606" ], "fei_number": [ "", "1000114111", "2221819", "3007513035", "3013188547", "3023530182", "2112667", "3010703925", "2020813", "3002558692", "1000122786", "3007238566", "3001104093", "3005783425", "3009156722", "3000126629", "1000639866", "3016618143", "3021559257", "3005803793", "3002807992", "3003319165", "3002807907", "3003589956", "3003513129", "3022543477", "3002808128", "3007603826", "3009129579", "3000957797", "2518157", "3010157426", "3014579161", "3035111606" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }