{ "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": "142560", "product_res_number": "Z-0680-2016", "event_date_initiated": "2015-12-15", "event_date_posted": "2016-01-21", "recall_status": "Terminated", "event_date_terminated": "2016-09-21", "res_event_number": "72943", "product_code": "BSZ", "k_numbers": [ "K110213" ], "product_description": "GE Healthcare, Aisys, 1011-9000-000.\n\nThe GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.", "code_info": "ANAU00153 ANAU00156 ANAU00152 ANAU00150 ANAU00151 ANAU00154 ANAU00155 ANAU00157 ANAU00158 ANAU00159 ANAU00160 ANAU00180 ANAU00181", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE Healthcare Service \n800-437-1171", "reason_for_recall": "The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.", "root_cause_description": "Nonconforming Material/Component", "action": "GE Healthcare sent an Urgent Medical Device Correction letter dated December 15, 2015, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.", "product_quantity": "13", "distribution_pattern": "Worldwide Distribution - US (nationwide including PR except NH, VT, & WY.\nInternationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.", "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" } } ] }