{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "31339", "product_res_number": "Z-0545-04", "event_date_initiated": "2004-02-03", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2005-11-17", "res_event_number": "28182", "product_code": "BSZ", "k_numbers": [ "K973985" ], "product_description": "Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units\n\n (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)", "code_info": "The affected units in the United States have serial numbers between 40013635 and 40162379.", "firm_fei_number": "2183066", "recalling_firm": "Datex-Ohmeda Inc", "address_1": "One Ohmeda Dr. Box 7550 One Ohmeda Dr.", "address_2": "Box 7550", "city": "Madison", "state": "WI", "postal_code": "53707", "additional_info_contact": "Mr. William Exner\n608-221-1551 Ext. 3115", "reason_for_recall": "Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.", "root_cause_description": "Other", "action": "Recall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.", "product_quantity": "1617 units in the United States", "distribution_pattern": "The product was distributed nationwide to hospitals in the Unites States.", "openfda": { "k_number": [ "K884879", "K930351", "K113633", "K252746", "K802591", "K073707", "K052335", "K151570", "K884802", "K972848", "K830159", "K973896", "K890410", "K861170", "K875350", "K041430", "K945463", "K852175", "K801103", "K872178", "K853435", "K061102", "K083098", "K882489", "K862085", "K001727", "K201957", "K930492", "K971425", "K160665", "K963994", "K903991", "K123211", "K172045", "K844421", "K072420", "K081844", "K921742", "K251352", "K142552", "K133886", "K771057", "K230931", "K840356", "K833335", "K801102", "K900937", "K171292", "K864644", "K102471", "K963481", "K822218", "K841274", "K032803", "K913791", "K894309", "K030624", "K850648", "K081447", "K041622", "K844849", "K103035", "K770554", "K973971", "K062155", "K973949", "K042154", "K042607", "K131945", "K781492", "K000859", "K033026", "K112114", "K982137", "K844012", "K893780", "K110213", "K132903", "K965041", "K965160", "K031400", "K170872", "K945722", "K003251", "K901713", "K010613", "K191027", "K902962", "K003579", "K042086", "K143530", "K830161", "K844008", "K935546", "K973985", "K001488", "K900328", "K841370", "K920944", "K884991", "K140264", "K253330", "K090892", "K760228", "K033498", "K083413", "K970163", "K122445", "K132530", "K933285", "K900329", "K833147", "K992421", "K863207", "K003663", "K974193", "K022031", "K853139", "K001315", "K171311", "K771479", "K830160", "K051629", "K854213", "K981845", "K901117", "K851621", "K971030", "K060193", "K092864", "K000706", "K800801", "K864806", "K123125", "K864447", "K983635", "K062388", "K081941", "K090233", "K790456", "K791530", "K864590", "K803052", "K213867", "K001988", "K923519", "K112722", "K050626", "K122063", "K862831", "K050676", "K905635", "K981530", "K101439", "K980553", "K030939", "K131790", "K120075", "K042419", "K061609", "K864589", "K040743", "K801100", "K050055", "K011404", "K901119", "K946127", "K151954", "K050883", "K102182", "K133958", "K071142", "K993410", "K903135", "K945234", "K923172", "K925580", "K934669", "K855022", "K080175", "K844563", "K000995", "K012446", "K071097", "K102389", "K771989", "K830680", "K833151", "K072884" ], "registration_number": [ "", "1530958", "3005783425", "1066427", "3009156722", "9710602", "2112667", "8043316", "9610531", "3003589956", "9617604", "3007603826", "1000122786", "3016618143", "3001104093", "3005803793", "2518157", "2221819", "1066270", "3010157426", "9611500", "3010703925", "8010042", "3007238566", "9611295", "3035111606", "3013188547", "3009129579", "1054713", "3021559257", "3000126629", "3022543477", "3014579161", "2020813" ], "fei_number": [ "", "3005783425", "3009156722", "3003513129", "2112667", "3023530182", "3003589956", "3007603826", "1000122786", "3016618143", "3001104093", "3005803793", "3002807907", "3003319165", "2518157", "2221819", "1000114111", "1000639866", "3000957797", "3010157426", "3002807992", "3010703925", "3002558692", "3007238566", "3035111606", "3013188547", "3007513035", "3009129579", "3021559257", "3000126629", "3022543477", "3002808128", "3014579161", "2020813" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }