{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121287", "product_res_number": "Z-0008-2014", "event_date_initiated": "2013-08-14", "event_date_posted": "2013-10-10", "recall_status": "Terminated", "event_date_terminated": "2014-09-23", "res_event_number": "66025", "product_code": "BSZ", "k_numbers": [ "K042419" ], "product_description": "Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M\n\nProduct Usage: \nused to administer anesthesia and ventilation to patients during surgical procedures.", "code_info": "Part Nos. 8607000 (GS Permium)  8606000 (Fabius OS and Fabius Tiro)  8608400 (Fabius Tiro D-M)ASEC-0055  with lot numbers: \t  ASEC-0186, ASED-0006, ASED-0074, ASED-0291, ASEC-0056, ASEC-0205, ASED-0007, SED-0075\tASED-0292, ASEC-0061, ASEC-0206, ASED-0020, ASED-0079, ASED-0293, ASEC-0062, ASEC-0207, ASED-0021, ASED-0139, ASED-0294, ASEC-0070, ASEC-0208, ASED-0023, ASED-0160, ASED-0295, ASEC-0071, ASEC-0209, ASED-0024, ASED-0161, ASED-0296, ASEC-0112, ASEC-0210, ASED-0025, ASED-0162, ASEE-0021, ASEC-0124, SEC-0211, ASED-0031, ASED-0163, ASEE-0022, ASEC-0125, ASEC-0212, ASED-0032, ASED-0164, ASEE-0023, ASEC-0126, ASEC-0213, ASED-0033, ASED-0165, ASEE-0041, ASEC-0169, ASEC-0214, ASED-0034, ASED-0166, ASEE-0042, ASEC-0170, ASEC-0236, ASED-0035, ASED-0167, ASEE-0058, ASEC-0171, ASEC-0248, ASED-0036, ASED-0168, ASEE-0060, ASEC-0172, ASEC-0249, ASED-0037, ASED-0169, ASEE-0061, ASEC-0173, ASEC-0250, ASED-0038, ASED-0203, ASEE-0065, ASEC-0174, ASED-0001, ASED-0044, ASED-0253, ASEE-0066, ASEC-0175, ASED-0002, ASED-0045, ASED-0286, ASEE-0083, ASEC-0176, ASED-0003, ASED-0046, ASED-0287, ASEE-0103, ASEC-0184, ASED-0004, ASED-0047, ASED-0288, ASEE-0136, ASEC-0185, ASED-0005, ASED-0051, ASED-0290, ASEC-0054, ASEC-0194, ASED-0247, ASED-0263, ASEE-0072, ASEC-0167, ASEC-0195, ASED-0248, ASED-0264, ASEE-0089,  ASEC-0178, ASEC-0196, ASED-0254, ASED-0265, ASEE-0090, ASEC-0179, ASEC-0197, ASED-0255, ASED-0266, ASEE-0131, ASEC-0180, ASEC-0227, ASED-0256, ASED-0282, ASEE-0132, ASEC-0181, ASEC-0228, ASED-0257, ASEE-0003, ASEE-0133, ASEC-0182, ASED-0040, ASED-0260, ASEE-0017, ASEE-0134, ASEC-0183, ASED-0086, ASED-0261, ASEE-0054, ASEC-0193, ASED-0245, ASED-0262, ASEE-0071, ASED-0141, ASED-0143, ASED-0145, ASED-0147, ASED-0149, ASED-0142, ASED-0144, ASED-0146, ASED-0148,  ASEB-0219", "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": "Draeger Medical Customer Service\n215-721-5400", "reason_for_recall": "During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.", "root_cause_description": "Device Design", "action": "The firm, Drager, sent an \"Urgent Medical Device Recall\" letter dated August 2013 to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that in the event of a failure, manual ventilation mode should be used and that Draeger reps would be contacting customers to schedule the replacement of the power supply. The customers were instructed to notify personnel accordingly.\n\nIf you have any questions, contact Director, Quality at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DragerService Technical Support at 1-800-543-5047 (press 4 at the prompt).", "product_quantity": "1127 units", "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania\nMalaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Senegal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, Vietnam, White Russia\nTurkmenistan.", "openfda": { "k_number": [ "K123211", "K800801", "K893780", "K102182", "K844849", "K160665", "K033026", "K844012", "K771989", "K151570", "K890410", "K042086", "K844421", "K830680", "K103035", "K092864", "K830159", "K864589", "K003579", "K863207", "K071097", "K010613", "K102471", "K122063", "K083098", "K131790", "K771057", "K172045", "K963994", "K844008", "K051629", "K872178", "K861170", "K900937", "K171311", "K081447", "K981530", "K253330", "K973896", "K913791", "K001988", "K862085", "K083413", "K170872", "K864806", "K945234", "K830161", "K903135", "K123125", "K884879", "K072420", "K032803", "K925580", "K852175", "K993410", "K945463", "K923519", "K864644", "K122445", "K142552", "K853139", "K921742", "K946127", "K791530", "K113633", "K062155", "K770554", "K000706", "K853435", "K042607", "K971030", "K945722", "K001315", "K071142", "K801102", "K884802", "K830160", "K771479", "K251352", "K963481", "K050883", "K011404", "K983635", "K930492", "K833147", "K062388", "K132530", "K833151", "K050676", "K901119", "K982137", "K252746", "K052335", "K850648", "K980553", "K974193", "K090892", "K802591", "K973971", "K143530", "K930351", "K140264", "K884991", "K031400", "K041430", "K090233", "K973985", "K822218", "K120075", "K191027", "K001727", "K970163", "K862831", "K042419", "K201957", "K902962", "K151954", "K920944", "K934669", "K875350", "K022031", "K171292", "K935546", "K833335", "K854213", "K133958", "K903991", "K061102", "K042154", "K981845", "K882489", "K133886", "K073707", "K131945", "K230931", "K101439", "K905635", "K840356", "K803052", "K864590", "K790456", "K992421", "K061609", "K844563", "K965041", "K112114", "K000859", "K801103", "K081844", "K112722", "K001488", "K050626", "K841274", "K781492", "K132903", "K973949", "K030939", "K050055", "K901713", "K864447", "K012446", "K965160", "K040743", "K213867", "K901117", "K060193", "K000995", "K760228", "K102389", "K900328", "K894309", "K971425", "K003663", "K030624", "K080175", "K851621", "K033498", "K841370", "K041622", "K801100", "K855022", "K072884", "K003251", "K933285", "K972848", "K081941", "K110213", "K923172", "K900329" ], "registration_number": [ "", "3005803793", "2518157", "3010703925", "2020813", "3013188547", "9611500", "3007238566", "3001104093", "3021559257", "1000122786", "1054713", "9611295", "3016618143", "3014579161", "3007603826", "1066270", "1066427", "8043316", "3022543477", "9617604", "3000126629", "2221819", "3009129579", "9610531", "3009156722", "2112667", "3010157426", "3005783425", "8010042", "9710602", "3003589956", "1530958", "3035111606" ], "fei_number": [ "", "3005803793", "2518157", "3010703925", "2020813", "3013188547", "3007238566", "3001104093", "3021559257", "1000122786", "1000639866", "3007513035", "1000114111", "3016618143", "3014579161", "3007603826", "3023530182", "3002558692", "3003319165", "3022543477", "3002808128", "3000126629", "3002807992", "3009129579", "2221819", "3009156722", "2112667", "3000957797", "3010157426", "3002807907", "3005783425", "3003513129", "3003589956", "3035111606" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }