{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "197513", "product_res_number": "Z-0959-2023", "event_date_initiated": "2022-12-22", "event_date_posted": "2023-01-26", "recall_status": "Open, Classified", "res_event_number": "91339", "product_code": "BSZ", "k_numbers": [ "K191027" ], "product_description": "Getinge Flow-i Anesthesia Systems\nFlow-i C20, Part no. 6677200\nFlow-i C30, Part no. 6677300\nFlow-i C40, Part no. 6677400", "code_info": "Part #\t UDI\n6677200\t7325710001349\nSerial Numbers 1202-8027\n\nPart #\t UDI\n6677300\t7325710001363\nSerial Numbers 1058-1201\n\nPart #\t UDI\n6677400\t7325710001318\nSerial Numbers 2034-8446\n\nSoftware versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.", "firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "additional_info_contact": "Stephanie Moretti\n973-709-7170", "reason_for_recall": "Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.", "root_cause_description": "Software Design Change", "action": "On December 22, 2022, the firm notified affected customers through Urgent Medical Device Correction letters.\n\nCustomers were instructed to examine their inventory immediately to determine if they have any of the affected serial numbers. If you have an affected system running on software version 4.8.0 through 4.8.3, you may continue use of the device until the software is updated with the following considerations:\n\n1. If during use, the device is switched from Automatic to Manual and it is found that the manual bag is empty the user can activate the Emergency ventilation or turn off/on the device to reset the disabled valves function.\n\n2. Users may also use the resuscitator that is available in the Operating Room.\n\nGetinge will update the software to correct the issue free of charge. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).", "product_quantity": "8,016 Total (7,766 OUS; 250 US)", "distribution_pattern": "US nationwide and Worldwide Distribution:\n\nDomestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.", "openfda": { "k_number": [ "K001988", "K935546", "K131790", "K900328", "K864447", "K090233", "K894309", "K113633", "K851621", "K112722", "K900329", "K122063", "K771989", "K840356", "K841370", "K251352", "K143530", "K901117", "K830159", "K875350", "K031400", "K102182", "K850648", "K882489", "K963481", "K790456", "K081844", "K062155", "K981845", "K791530", "K980553", "K945722", "K033498", "K844421", "K060193", "K101439", "K971425", "K972848", "K862085", "K983635", "K123211", "K864806", "K151570", "K760228", "K923172", "K945234", "K855022", "K120075", "K050883", "K973985", "K071097", "K965160", "K822218", "K042154", "K872178", "K030624", "K160665", "K890410", "K803052", "K172045", "K201957", "K920944", "K081447", "K801103", "K982137", "K030939", "K833335", "K862831", "K900937", "K884879", "K050055", "K830160", "K946127", "K052335", "K853435", "K170872", "K973896", "K041622", "K010613", "K061609", "K841274", "K073707", "K933285", "K132903", "K213867", "K102471", "K003251", "K852175", "K781492", "K884802", "K253330", "K921742", "K973949", "K000706", "K171292", "K081941", "K131945", "K072884", "K974193", "K103035", "K252746", "K042607", "K003579", "K032803", "K000859", "K833147", "K864644", "K902962", "K925580", "K151954", "K230931", "K854213", "K191027", "K771057", "K122445", "K771479", "K123125", "K140264", "K981530", "K770554", "K011404", "K802591", "K083413", "K903135", "K061102", "K973971", "K833151", "K934669", "K905635", "K800801", "K022031", "K801100", "K913791", "K923519", "K993410", "K133886", "K830680", "K844012", "K012446", "K080175", "K042419", "K083098", "K050626", "K844008", "K092864", "K930351", "K930492", "K971030", "K142552", "K001727", "K863207", "K033026", "K040743", "K970163", "K963994", "K041430", "K062388", "K830161", "K042086", "K050676", "K003663", "K861170", "K945463", "K893780", "K090892", "K853139", "K864590", "K132530", "K102389", "K901713", "K072420", "K965041", "K844563", "K801102", "K903991", "K844849", "K901119", "K001488", "K000995", "K001315", "K884991", "K071142", "K051629", "K864589", "K110213", "K112114", "K133958", "K171311", "K992421" ], "registration_number": [ "", "3001104093", "1530958", "3005783425", "1054713", "3009156722", "3010157426", "2020813", "3003589956", "8010042", "9710602", "1066270", "2518157", "3016618143", "9611500", "3021559257", "1000122786", "3010703925", "3014579161", "2221819", "9617604", "9611295", "3000126629", "3022543477", "8043316", "3035111606", "3007238566", "3013188547", "3009129579", "1066427", "3005803793", "3007603826", "2112667", "9610531" ], "fei_number": [ "", "3001104093", "3000957797", "3005783425", "3002808128", "3009156722", "3010157426", "3002807907", "3002807992", "2020813", "3003589956", "1000639866", "2518157", "3016618143", "3021559257", "3002558692", "1000122786", "3010703925", "3014579161", "1000114111", "2221819", "3003513129", "3000126629", "3007513035", "3022543477", "3035111606", "3023530182", "3007238566", "3013188547", "3003319165", "3009129579", "3005803793", "3007603826", "2112667" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }