{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221405", "product_res_number": "Z-2860-2026", "event_date_initiated": "2026-06-24", "event_date_posted": "2026-08-03", "recall_status": "Open, Classified", "res_event_number": "99359", "product_code": "BSZ", "k_numbers": [ "K191027" ], "product_description": "Flow Anesthesia Machine\n\nFlow-i C20 6677200\nFlow-i C30 6677300\nFlow-i C40 6677400\nFlow-i C20 6888520\nFlow-i C30 6888530\nFlow-i C40 6888540\nFlow-c 6887700\nFlow-e 6887900", "code_info": "Flow-i C20 6677200 / UDI-DI 07325710001349\nFlow-i C30 6677300 / UDI-DI 07325710001363\nFlow-i C40 6677400 / UDI-DI 07325710001318\nFlow-i C20 6888520 / UDI-DI 07325710010617\nFlow-i C30 6888530 / UDI-DI 07325710010624\nFlow-i C40 6888540 / UDI-DI 07325710010631\nFlow-c 6887700 / UDI-DI 07325710009765\nFlow-e 6887900 / UDI-DI 07325710010457\n\nSoftware versions 4.8, 4.10, and 4.11.", "firm_fei_number": "3002808128", "recalling_firm": "Maquet Critical Care AB", "address_1": "Rontgenvagen 2 2 rontgenvagen", "city": "Solna", "country": "Sweden", "additional_info_contact": "Megan Ties\n103357300", "reason_for_recall": "Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.", "root_cause_description": "Under Investigation by firm", "action": "On June 24, 2026, the firm began issuing \"Urgent Medical Device Correction\" letters via FedEx to customers at the Risk Manager level.\n\nCustomers were informed that according to the Instructions for Use, this indication signifies that concentration levels are below detectable limits, serving as confirmation that no agent is present: **/gas analyzer has no information to display\n\nCustomers were given recommended precautions to identify and mitigate the issue, such as confirming that the anesthetic agent is being delivered after activating the vaporizer, and continuously monitoring end-tidal anesthetic agent concentration and patient vital signs to ensure adequate anesthesia is maintained. If delivery is not confirmed, end case and start up again.\n\nThe firm has developed a software update, version 4.8.7, which will improve stability during case start-up, thereby reducing the risk of no anesthetic agent delivery events.\n\nCustomers are instructed to identify all affected product in their inventory and notify any individuals within their organization or where the affected devices have been transferred.\n\nCustomers should contact their local Getinge representative to assist with downloading the updated software.", "product_quantity": "408 US; 11,342 OUS", "distribution_pattern": "Worldwide - US Nationwide distribution to the states of AL, AR, CA, CO, DC, DE, FL, GA, IN, \nMA, MI, MO, NY, OH, OR, PA, SC, TX, VA, WA, WV.", "openfda": { "k_number": [ "K970163", "K052335", "K983635", "K844008", "K965041", "K790456", "K830680", "K862831", "K864589", "K875350", "K963481", "K791530", "K946127", "K800801", "K921742", "K251352", "K171292", "K901713", "K933285", "K802591", "K042419", "K882489", "K201957", "K001315", "K923172", "K071142", "K903135", "K844421", "K122445", "K003663", "K884802", "K974193", "K893780", "K003251", "K981530", "K840356", "K862085", "K900329", "K073707", "K081447", "K143530", "K844563", "K103035", "K801103", "K140264", "K050626", "K133958", "K900328", "K090233", "K001727", "K033026", "K930492", "K901119", "K191027", "K973985", "K080175", "K903991", "K872178", "K864644", "K253330", "K050676", "K884991", "K864447", "K000706", "K851621", "K861170", "K133886", "K113633", "K252746", "K123211", "K151954", "K844012", "K003579", "K973971", "K081941", "K030939", "K801102", "K131790", "K854213", "K833335", "K230931", "K041430", "K905635", "K973896", "K151570", "K853139", "K102182", "K853435", "K060193", "K030624", "K760228", "K863207", "K042154", "K072420", "K000859", "K061102", "K072884", "K062388", "K884879", "K963994", "K042607", "K771989", "K012446", "K112722", "K132530", "K852175", "K801100", "K902962", "K803052", "K890410", "K971030", "K010613", "K770554", "K102389", "K980553", "K123125", "K900937", "K071097", "K972848", "K945722", "K971425", "K101439", "K992421", "K001988", "K830160", "K771057", "K050883", "K864590", "K000995", "K771479", "K822218", "K132903", "K913791", "K920944", "K894309", "K032803", "K083413", "K131945", "K841370", "K945234", "K925580", "K040743", "K033498", "K120075", "K930351", "K081844", "K090892", "K945463", "K973949", "K172045", "K171311", "K022031", "K993410", "K965160", "K112114", "K935546", "K841274", "K781492", "K170872", "K160665", "K011404", "K833151", "K982137", "K031400", "K041622", "K901117", "K850648", "K102471", "K051629", "K981845", "K092864", "K122063", "K110213", "K061609", "K830161", "K923519", "K001488", "K864806", "K844849", "K050055", "K855022", "K042086", "K934669", "K083098", "K062155", "K213867", "K142552", "K830159", "K833147" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2", "registration_number": [ "", "3021559257", "1530958", "8043316", "2221819", "3010703925", "9710602", "3000126629", "3007238566", "1054713", "3005803793", "2518157", "3005783425", "9611500", "3016618143", "9617604", "3009156722", "3014579161", "1000122786", "3009129579", "3013188547", "2020813", "3003589956", "3035111606", "8010042", "9611295", "3022543477", "3001104093", "1066427", "3007603826", "3010157426", "9610531", "2112667", "1066270" ], "fei_number": [ "", "3021559257", "3003513129", "2221819", "3010703925", "3000126629", "3007238566", "3002807992", "3005803793", "3002558692", "2518157", "3005783425", "3003319165", "3002808128", "3016618143", "3002807907", "3000957797", "3009156722", "3014579161", "1000122786", "3009129579", "3023530182", "3013188547", "2020813", "3003589956", "3035111606", "1000639866", "3022543477", "3001104093", "3007603826", "3010157426", "1000114111", "2112667", "3007513035" ] } } ] }