{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183935", "product_res_number": "Z-0314-2021", "event_date_initiated": "2020-09-17", "event_date_created": "2020-10-30", "recall_status": "Open, Classified", "res_event_number": "86531", "product_code": "BSZ", "k_numbers": [ "K172045" ], "product_description": "9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.", "code_info": "Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020)", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, 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": "Flow sensors could have damaged tubes in the form of small punctures or cuts.", "root_cause_description": "Process control", "action": "GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide\nsafety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable.\n\nIn the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager.\n\nGE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.", "product_quantity": "37 devices", "distribution_pattern": "U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI\n\nForeign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom", "openfda": { "k_number": [ "K123211", "K800801", "K893780", "K102182", "K844849", "K160665", "K033026", "K844012", "K771989", "K151570", "K890410", "K042086", "K844421", "K830680", "K103035", "K092864", "K830159", "K864589", "K003579", "K863207", "K071097", "K010613", "K102471", "K122063", "K083098", "K131790", "K771057", "K172045", "K963994", "K844008", "K051629", "K872178", "K861170", "K900937", "K171311", "K081447", "K981530", "K253330", "K973896", "K913791", "K001988", "K862085", "K083413", "K170872", "K864806", "K945234", "K830161", "K903135", "K123125", "K884879", "K072420", "K032803", "K925580", "K852175", "K993410", "K945463", "K923519", "K864644", "K122445", "K142552", "K853139", "K921742", "K946127", "K791530", "K113633", "K062155", "K770554", "K000706", "K853435", "K042607", "K971030", "K945722", "K001315", "K071142", "K801102", "K884802", "K830160", "K771479", "K251352", "K963481", "K050883", "K011404", "K983635", "K930492", "K833147", "K062388", "K132530", "K833151", "K050676", "K901119", "K982137", "K252746", "K052335", "K850648", "K980553", "K974193", "K090892", "K802591", "K973971", "K143530", "K930351", "K140264", "K884991", "K031400", "K041430", "K090233", "K973985", "K822218", "K120075", "K191027", "K001727", "K970163", "K862831", "K042419", "K201957", "K902962", "K151954", "K920944", "K934669", "K875350", "K022031", "K171292", "K935546", "K833335", "K854213", "K133958", "K903991", "K061102", "K042154", "K981845", "K882489", "K133886", "K073707", "K131945", "K230931", "K101439", "K905635", "K840356", "K803052", "K864590", "K790456", "K992421", "K061609", "K844563", "K965041", "K112114", "K000859", "K801103", "K081844", "K112722", "K001488", "K050626", "K841274", "K781492", "K132903", "K973949", "K030939", "K050055", "K901713", "K864447", "K012446", "K965160", "K040743", "K213867", "K901117", "K060193", "K000995", "K760228", "K102389", "K900328", "K894309", "K971425", "K003663", "K030624", "K080175", "K851621", "K033498", "K841370", "K041622", "K801100", "K855022", "K072884", "K003251", "K933285", "K972848", "K081941", "K110213", "K923172", "K900329" ], "registration_number": [ "", "3005803793", "2518157", "3010703925", "2020813", "3013188547", "9611500", "3007238566", "3001104093", "3021559257", "1000122786", "1054713", "9611295", "3016618143", "3014579161", "3007603826", "1066270", "1066427", "8043316", "3022543477", "9617604", "3000126629", "2221819", "3009129579", "9610531", "3009156722", "2112667", "3010157426", "3005783425", "8010042", "9710602", "3003589956", "1530958", "3035111606" ], "fei_number": [ "", "3005803793", "2518157", "3010703925", "2020813", "3013188547", "3007238566", "3001104093", "3021559257", "1000122786", "1000639866", "3007513035", "1000114111", "3016618143", "3014579161", "3007603826", "3023530182", "3002558692", "3003319165", "3022543477", "3002808128", "3000126629", "3002807992", "3009129579", "2221819", "3009156722", "2112667", "3000957797", "3010157426", "3002807907", "3005783425", "3003513129", "3003589956", "3035111606" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }