{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "90650", "product_res_number": "Z-1526-2010", "event_date_initiated": "2010-03-12", "event_date_posted": "2010-05-11", "recall_status": "Terminated", "event_date_terminated": "2012-01-30", "res_event_number": "55355", "product_code": "BSZ", "k_numbers": [ "K090233" ], "product_description": "GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor", "code_info": "Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873", "firm_fei_number": "2126677", "recalling_firm": "Ge Healthcare, Llc", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "262-544-3894", "reason_for_recall": "Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.", "root_cause_description": "Process design", "action": "Consignees were sent a GE Healthcare \"Urgent Medical Device Correction\" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering.\nThe letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.", "product_quantity": "15 (OUS)", "distribution_pattern": "Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.", "openfda": { "k_number": [ "K112722", "K981845", "K923172", "K983635", "K171292", "K791530", "K092864", "K864806", "K000859", "K930492", "K973971", "K923519", "K061609", "K884879", "K864590", "K133886", "K022031", "K102182", "K080175", "K062155", "K771989", "K041622", "K101439", "K081941", "K071097", "K102471", "K864589", "K120075", "K253330", "K844849", "K071142", "K122063", "K901713", "K894309", "K800801", "K830161", "K850648", "K844563", "K862831", "K945463", "K251352", "K841274", "K000706", "K862085", "K151954", "K853139", "K971425", "K982137", "K833335", "K131945", "K934669", "K760228", "K133958", "K803052", "K973949", "K855022", "K920944", "K930351", "K946127", "K884991", "K112114", "K801100", "K081447", "K050626", "K050055", "K852175", "K905635", "K854213", "K061102", "K110213", "K900937", "K973985", "K771479", "K042419", "K853435", "K980553", "K142552", "K864447", "K171311", "K033026", "K073707", "K945234", "K882489", "K965160", "K830160", "K901117", "K123125", "K861170", "K050676", "K771057", "K833147", "K050883", "K963481", "K890410", "K030624", "K851621", "K090892", "K000995", "K872178", "K131790", "K040743", "K935546", "K042086", "K032803", "K884802", "K132903", "K030939", "K172045", "K972848", "K123211", "K901119", "K143530", "K122445", "K042607", "K981530", "K003663", "K151570", "K863207", "K191027", "K001727", "K230931", "K864644", "K893780", "K001315", "K900329", "K921742", "K081844", "K970163", "K801103", "K003251", "K974193", "K213867", "K844008", "K090233", "K992421", "K011404", "K083098", "K170872", "K132530", "K963994", "K933285", "K830159", "K993410", "K001488", "K160665", "K913791", "K060193", "K802591", "K965041", "K062388", "K031400", "K072884", "K841370", "K844421", "K790456", "K042154", "K875350", "K103035", "K945722", "K003579", "K033498", "K113633", "K252746", "K051629", "K903991", "K083413", "K902962", "K840356", "K102389", "K844012", "K925580", "K001988", "K201957", "K052335", "K010613", "K041430", "K822218", "K072420", "K830680", "K903135", "K012446", "K971030", "K770554", "K833151", "K801102", "K900328", "K973896", "K781492", "K140264" ], "registration_number": [ "1054713", "3014579161", "3007603826", "3005783425", "9610531", "3007238566", "1066427", "3013188547", "9617604", "3021559257", "3049808762", "9710602", "2112667", "2221819", "3010703925", "3022543477", "2518157", "3003589956", "3035111606", "8043316", "1000122786", "1066270", "9611500", "2020813", "8010042", "3009156722", "9611295", "3000126629", "3009129579", "3016618143", "3005803793", "3010157426", "1530958" ], "fei_number": [ "1000639866", "3014579161", "3007603826", "3005783425", "3002558692", "3007238566", "3002808128", "3013188547", "3002807907", "3007513035", "3021559257", "3049808762", "2112667", "2221819", "3010703925", "3022543477", "2518157", "3003513129", "3003589956", "3035111606", "1000122786", "3002807992", "2020813", "3009156722", "3000126629", "3009129579", "3001104093", "3016618143", "3005803793", "3010157426", "1000114111", "3000957797", "3003319165" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }