{ "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": "42272", "product_res_number": "Z-0038-06", "event_date_initiated": "2005-09-27", "event_date_posted": "2005-10-12", "recall_status": "Terminated", "event_date_terminated": "2007-04-01", "res_event_number": "33678", "product_code": "BSZ", "k_numbers": [ "K050626" ], "product_description": "Datex-Ohmeda S/5 Aespire Anesthesia System 7900", "code_info": "ANCJ00100 thru ANCJ00113, ANCJ00116, ANCJ00118", "firm_fei_number": "2183066", "recalling_firm": "Datex-Ohmeda Inc", "address_1": "3030 Ohmeda Drive", "address_2": "PO Box 7550", "city": "Madison", "state": "WI", "postal_code": "53718", "reason_for_recall": "Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.", "root_cause_description": "Other", "action": "Urgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.", "product_quantity": "16", "distribution_pattern": "CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Republic, Ecuador, Finland, France, \nGermany, Ghana, Great Britain, Hong Kong, India, Indonesia, \nIsrael, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, \nMalaysia, Mexico, Oman, Palestine, Peru, Poland, Portugal, \nSaudi Arabia, Slovenia, South Africa, Spain, Switzerland, \nUnited Arab Emerites, Venezuela & Vietnam.", "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" } } ] }