{ "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": 4 } }, "results": [ { "cfres_id": "222074", "product_res_number": "Z-3189-2026", "event_date_initiated": "2026-07-30", "event_date_posted": "2026-09-16", "recall_status": "Open, Classified", "res_event_number": "99649", "product_code": "BSZ", "k_numbers": [ "K172045" ], "product_description": "Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000", "code_info": "UDI-DI: 00840682102292;\nSerial Numbers: 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"firm_fei_number": "2112667", "recalling_firm": "Datex-Ohmeda, Inc.", "address_1": "3030 Ohmeda Dr", "city": "Madison", "state": "WI", "postal_code": "53718-6704", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/30/26 was sent to customers.\n\nActions to be taken by Customer/User\nPending corrections from GE HealthCare, you can continue to use your Anesthesia system by following the instruction below:\n1. Prior to each use, complete preoperative checkout and tests in accordance with the instructions in the User Reference Manual (URM).\n2. When Alternate O2 control is enabled, the clinician should adjust the Alternate O2 flow as appropriate for the case. Use the Alternate O2 control knob to adjust the O2 flow.\n3. When Alternate O2 control is enabled, flow from the electronic mixer is stopped and the agent concentration is set to off. Two situations are possible regarding the Agent quick key:\na. The Agent quick key will be blank on the display if agent delivery is unavailable. Supplement with or transition to intravenous anesthetics as needed.\nb. The Agent quick key will be present on the display if agent delivery can be resumed. Press the Agent quick key to set the desired concentration and press the key again to confirm.\n4. Please evaluate existing service stock for the Field Replaceable Unit (FRU) spare parts listed below and dispose of all affected FRU parts according to your facility procedures.\nPlease ensure all potential staff in your facility are made aware of this safety notification and the recommended actions.\nPlease retain this document for your records.\nPlease complete and return the attached acknowledgement form electronically via FMI 34147 Digital Response Form or print, fill out manually, scan, and email to recall.34147@gehealthcare.com.\n\nProduct Correction\nGE HealthCare will inspect and correct as necessary all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction.\nContact Information\nIf you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "475 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "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" } } ] }