{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196696", "product_res_number": "Z-0422-2023", "event_date_initiated": "2022-11-07", "event_date_posted": "2022-12-07", "recall_status": "Open, Classified", "res_event_number": "91088", "product_code": "BSZ", "k_numbers": [ "K191027" ], "product_description": "Flow-c Anesthesia System (Product Code 6887700)\nFlow-e Anesthesia System (Product Code 6887900)", "code_info": "Flow-c\nUDI-DI: 7325710010457\nLot/Serial Numbers\n4003\n4777\n4783\n5024\n5025\n5026\n5027\n5028\n5043\n5044\n5045\n5046\n5047\n5048\n5049\n5050\n5078\n\nFlow-e\nUDI-DI: 7325710009765\nLot/Serial Numbers\n50012\n50013\n50014\n50015\n50016\n50017\n50030\n50031\n50033\n50034\n50035\n50036\n50037\n50038\n50039\n50040\n50041\n50042\n50043\n50046\n50047\n50048\n50051\n50052\n50053\n50054\n50055\n50056\n50057\n50058\n50059\n50060\n50061\n50062\n50069\n50070\n50071\n50072\n50073\n50074\n50084\n50085\n50086\n50087\n50088\n50089\n50090\n50091\n50092\n50093\n50094\n50096\n50097\n50108\n50109\n50110\n50111\n50132", "firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "reason_for_recall": "The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.", "root_cause_description": "Component design/selection", "action": "On 11/7/22 the firm notified customers via Urgent Medical Device Correction letters.\n\nCustomers were instructed to immediately identify whether they had affected Flow-c or Flow-e anesthesia systems on hand. Customers who have affected devices may continue to use the device ensuring that a system checkout procedure is performed per the Operators Manual.\n\nThe firm will replace the Power backup battery free of charge for customers with affected anesthesia systems. You can also 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": "65 US", "distribution_pattern": "US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.", "openfda": { "k_number": [ "K840356", "K862085", "K033026", "K833335", "K001488", "K042086", "K133886", "K901119", "K862831", "K830680", "K012446", "K142552", "K923172", "K123211", "K893780", "K050883", "K894309", "K935546", "K041430", "K032803", "K122445", "K983635", "K110213", "K973985", "K980553", "K971425", "K151954", "K992421", "K923519", "K120075", "K132903", "K112722", "K903991", "K172045", "K771057", "K841274", "K151570", "K901713", "K030939", "K852175", "K071097", "K855022", "K050626", "K030624", "K830161", "K833151", "K042154", "K965160", "K913791", "K252746", "K771989", "K833147", "K171311", "K801103", "K982137", "K830159", "K123125", "K131790", "K132530", "K920944", "K251352", "K103035", "K000859", "K003251", "K041622", "K875350", "K760228", "K905635", "K844563", "K071142", "K042607", "K160665", "K973896", "K863207", "K902962", "K800801", "K884991", "K102471", "K945722", "K051629", "K981530", "K092864", "K201957", "K113633", "K011404", "K822218", "K900329", "K060193", "K122063", "K801100", "K230931", "K884802", "K090892", "K864590", "K052335", "K010613", "K970163", "K946127", "K972848", "K081844", "K921742", "K903135", "K844012", "K981845", "K973971", "K850648", "K081941", "K040743", "K853139", "K081447", "K191027", "K771479", "K802591", "K062155", "K000706", "K143530", "K861170", "K083098", "K003663", "K965041", "K022031", "K930351", "K050676", "K050055", "K841370", "K791530", "K140264", "K900937", "K003579", "K042419", "K963994", "K072420", "K934669", "K803052", "K864589", "K971030", "K945463", "K844008", "K844849", "K102182", "K781492", "K864806", "K790456", "K933285", "K083413", "K901117", "K900328", "K973949", "K851621", "K131945", "K253330", "K882489", "K073707", "K854213", "K133958", "K170872", "K061102", "K171292", "K801102", "K853435", "K864644", "K033498", "K001727", "K080175", "K000995", "K770554", "K062388", "K101439", "K061609", "K213867", "K072884", "K993410", "K884879", "K945234", "K031400", "K102389", "K872178", "K974193", "K844421", "K890410", "K001315", "K930492", "K963481", "K001988", "K864447", "K112114", "K925580", "K090233", "K830160" ], "registration_number": [ "", "1530958", "2221819", "8010042", "3013188547", "2112667", "3010703925", "2020813", "1000122786", "9611295", "3007238566", "3001104093", "3005783425", "3009156722", "3000126629", "9710602", "9610531", "8043316", "3016618143", "3021559257", "3005803793", "1066427", "1066270", "3003589956", "9617604", "3022543477", "3007603826", "3009129579", "9611500", "2518157", "3010157426", "1054713", "3014579161", "3035111606" ], "fei_number": [ "", "1000114111", "2221819", "3007513035", "3013188547", "3023530182", "2112667", "3010703925", "2020813", "3002558692", "1000122786", "3007238566", "3001104093", "3005783425", "3009156722", "3000126629", "1000639866", "3016618143", "3021559257", "3005803793", "3002807992", "3003319165", "3002807907", "3003589956", "3003513129", "3022543477", "3002808128", "3007603826", "3009129579", "3000957797", "2518157", "3010157426", "3014579161", "3035111606" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }