{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "47879", "product_res_number": "Z-0021-2007", "event_date_initiated": "2006-08-10", "event_date_posted": "2006-11-07", "recall_status": "Terminated", "event_date_terminated": "2008-02-24", "res_event_number": "36057", "product_code": "BSZ", "k_numbers": [ "K061609" ], "product_description": "GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company", "code_info": "Serial numbers: ANAK00115, ANAH00114, ANAH00115, ANAH00116, ANAH00117, ANAH00124, ANAH00126, ANAJ00100, ANAJ00101, ANAJ00102, ANAJ00103, ANAJ00104, ANAJ00105, ANAJ00106, ANAJ00107, ANAJ00108, ANAJ00109, ANAJ00110, ANAJ00111, ANAJ00112, 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"recalling_firm": "Datex - Ohmeda, Inc", "address_1": "Po Box 7550", "address_2": "Po Box 7550", "city": "Madison", "state": "WI", "postal_code": "53707", "additional_info_contact": "608-221-1551", "reason_for_recall": "Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.", "root_cause_description": "Other", "action": "Firm mailed recall letters on August 10, 2006, to consignees telling them what to do if a failure occurred during system checkout or during use, as a short term solution. Later, GE representatives will make visits to each site for modification of the interface valve on each device, as the long term solution.", "product_quantity": "471", "distribution_pattern": "AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,", "openfda": { "k_number": [ "K170872", "K790456", "K042607", "K770554", "K112114", "K993410", "K032803", "K854213", "K151570", "K921742", "K800801", "K101439", "K122445", "K973896", "K844421", "K903135", "K965160", "K830159", "K120075", "K072884", "K981845", "K000995", "K923519", "K791530", "K103035", "K884879", "K030939", "K945722", "K935546", "K771479", "K971030", "K963481", "K003251", "K903991", "K131945", "K803052", "K191027", "K802591", "K974193", "K171292", "K841370", "K882489", "K760228", "K893780", "K973971", "K083098", "K050626", "K830680", "K033026", "K041622", "K060193", "K071142", "K000706", "K963994", "K850648", "K945234", "K031400", "K853435", "K042419", "K901119", "K251352", "K844849", "K970163", "K853139", "K930492", "K102389", "K844563", "K890410", "K901713", "K132530", "K864590", "K062388", "K051629", "K900329", "K133958", "K011404", "K201957", "K844008", "K971425", "K864806", "K213867", "K973949", "K933285", "K042154", "K252746", "K062155", "K132903", "K864589", "K102471", "K946127", "K983635", "K905635", "K822218", "K001727", "K833335", "K253330", "K980553", "K830161", "K863207", "K945463", "K833147", "K110213", "K884991", "K982137", "K884802", "K050055", "K131790", "K894309", "K081844", "K900937", "K122063", "K902962", "K872178", "K123125", "K864447", "K801100", "K830160", "K003579", "K000859", "K061102", "K052335", "K071097", "K033498", "K230931", "K040743", "K913791", "K771057", "K992421", "K923172", "K001488", "K113633", "K833151", "K080175", "K151954", "K781492", "K801102", "K022031", "K771989", "K092864", "K972848", "K081447", "K930351", "K841274", "K862831", "K061609", "K171311", "K142552", "K003663", "K852175", "K143530", "K172045", "K965041", "K072420", "K140264", "K864644", "K041430", "K042086", "K083413", "K123211", "K973985", "K133886", "K081941", "K801103", "K840356", "K090892", "K901117", "K160665", "K050883", "K934669", "K001315", "K102182", "K073707", "K030624", "K012446", "K920944", "K001988", "K050676", "K861170", "K900328", "K851621", "K862085", "K855022", "K090233", "K844012", "K925580", "K112722", "K981530", "K010613", "K875350" ], "registration_number": [ "", "3022543477", "3003589956", "3014579161", "3005783425", "3010157426", "2221819", "3001104093", "8043316", "3035111606", "3013188547", "9617604", "9710602", "1066270", "3021559257", "9610531", "3009129579", "3009156722", "1054713", "2020813", "9611295", "3016618143", "1530958", "8010042", "2518157", "1066427", "2112667", "1000122786", "3005803793", "3007603826", "3000126629", "3007238566", "3010703925", "9611500" ], "fei_number": [ "", "3022543477", "3002808128", "3003589956", "3002807907", "3014579161", "3005783425", "3010157426", "2221819", "3001104093", "3035111606", "3000957797", "3013188547", "1000639866", "3007513035", "3003513129", "3021559257", "3009129579", "3009156722", "3023530182", "2020813", "3003319165", "3016618143", "3002807992", "2518157", "2112667", "1000122786", "3005803793", "3007603826", "3000126629", "3007238566", "3002558692", "1000114111", "3010703925" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }