{ "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": 2 } }, "results": [ { "cfres_id": "188580", "product_res_number": "Z-2595-2021", "event_date_initiated": "2021-08-02", "event_date_created": "2021-09-30", "recall_status": "Open, Classified", "res_event_number": "88400", "product_code": "BSZ", "k_numbers": [ "K172045" ], "product_description": "Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines:\n\n2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable)\n2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable)\n2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable)\n2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable)\n2096513-001-S FLOW SENSOR ASSEMBLY\n5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG\n5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG", "code_info": "Flow sensors with date of manufacture prior to 2021-06 etched on body of the flow sensor.", "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": "800-437-1171", "reason_for_recall": "The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.", "root_cause_description": "Under Investigation by firm", "action": "The recalling firm issued Urgent Medical Device Correction letters on 8/2/2021 via FedEx explaining the safety issue. This letter informs the customer of the issue and provides safety instructions, including requesting the consignee inspect all inventory of flow sensors. GE Healthcare will replace the flow sensors indicated on returned customer response forms, when applicable. The consignee will be responsible for replacing the flow sensor.\n\nThe letter was sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, Health Care Administrator / Risk Manager", "product_quantity": "Estimated 310,072 flow sensors", "distribution_pattern": "Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Mauritius, Mexico, Moldova, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Uruguay, Venezuela, Vietnam, and Yemen.", "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" } } ] }