{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "43016", "product_res_number": "Z-0857-06", "event_date_initiated": "2005-11-16", "event_date_posted": "2006-05-09", "recall_status": "Terminated", "event_date_terminated": "2007-01-23", "res_event_number": "34050", "product_code": "BSZ", "k_numbers": [ "K973985" ], "product_description": "Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)", "code_info": "6025108 thru 6025111, 6025114 thru 6025117, 6025119, 6025120, 6025122 thru 6025128, 6025130 thru 6025132, 6025134, 6025136, 6025137, 6035737, 6035738, 6035740 thru 6035745, 6035747, 6035751, 6035757, 6035758, 6035760, 6035762, 6035765, 6035772 thru 6035774, 6035784, 6048756 thru 6048761, 6048764, 6048847, 6048849, 6048853 thru 6048856 and 40300736", "firm_fei_number": "2183066", "recalling_firm": "GE Healthcare", "address_1": "3030 Ohmeda Drive", "address_2": "PO Box 7550", "city": "Madison", "state": "WI", "postal_code": "53718", "reason_for_recall": "Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.", "root_cause_description": "Other", "action": "Customers were sent a letter dated November 16, 2005, informing them of the possible alarm failure and giving them short term and long term solutions. Short term, clinicians are to: 1) check the audio alarm prior to use; and 2) use the ADU in conjunction with functioning anesthetic agent monitor. In the long term a GE Healthcare representative will contact the facility and schedule a visit to implement the corrective action at no charge.", "product_quantity": "113---(USA-61--International-52)", "distribution_pattern": "Worldwide---USA-States of AZ, CA, IA, MI, TX, and WI ----International- Australia, Austria, Belgium, Finland, Germany, Israel, Italy, Jordan, Malaysia, Netherlands, Norway, Portugal, Slovakia, South Africa, and Turkey.", "openfda": { "k_number": [ "K802591", "K791530", "K112722", "K923172", "K213867", "K981530", "K030939", "K930351", "K850648", "K010613", "K072420", "K151570", "K781492", "K884802", "K071142", "K050055", "K003663", "K132530", "K884879", "K090892", "K864644", "K801100", "K971425", "K131790", "K041430", "K062155", "K072884", "K890410", "K102389", "K083413", "K170872", "K000859", "K102471", "K801103", "K900328", "K855022", "K133958", "K844849", "K872178", "K972848", "K905635", "K771479", "K011404", "K061102", "K001727", "K925580", "K982137", "K042154", "K882489", "K041622", "K000706", "K862085", "K930492", "K830159", "K833147", "K800801", "K003251", "K081844", "K230931", "K980553", "K840356", "K201957", "K060193", "K030624", "K050883", "K971030", "K853435", "K050676", "K131945", "K900937", "K864806", "K801102", "K854213", "K790456", "K973949", "K862831", "K965041", "K963481", "K071097", "K771989", "K945722", "K822218", "K852175", "K875350", "K120075", "K171292", "K945234", "K833335", "K073707", "K101439", "K033498", "K103035", "K191027", "K081447", "K920944", "K973971", "K853139", "K973985", "K894309", "K251352", "K992421", "K760228", "K861170", "K963994", "K830161", "K946127", "K051629", "K001988", "K143530", "K844563", "K012446", "K171311", "K901117", "K133886", "K123125", "K080175", "K903991", "K140264", "K864589", "K081941", "K841274", "K900329", "K122063", "K983635", "K921742", "K031400", "K935546", "K042086", "K901119", "K974193", "K934669", "K122445", "K001488", "K040743", "K803052", "K844421", "K902962", "K003579", "K863207", "K052335", "K970163", "K933285", "K923519", "K771057", "K172045", "K042419", "K062388", "K841370", "K132903", "K903135", "K893780", "K102182", "K112114", "K945463", "K830160", "K001315", "K110213", "K032803", "K864447", "K973896", "K160665", "K965160", "K830680", "K113633", "K090233", "K844012", "K913791", "K083098", "K092864", "K142552", "K993410", "K151954", "K123211", "K033026", "K901713", "K981845", "K022031", "K050626", "K844008", "K864590", "K061609", "K833151", "K770554", "K884991", "K000995", "K252746", "K851621", "K042607", "K253330" ], "registration_number": [ "", "3009156722", "3007238566", "9610531", "1066270", "9611500", "3005783425", "3013188547", "9611295", "3000126629", "3001104093", "2518157", "1000122786", "3003589956", "8043316", "3007603826", "3035111606", "3005803793", "2112667", "3022543477", "2020813", "9617604", "1066427", "3014579161", "8010042", "3010157426", "3009129579", "1530958", "3021559257", "2221819", "9710602", "3016618143", "3010703925", "1054713" ], "fei_number": [ "", "3009156722", "3007238566", "3003513129", "3000957797", "1000114111", "3005783425", "3013188547", "3003319165", "3000126629", "3023530182", "3001104093", "2518157", "1000122786", "3002807907", "3003589956", "3002807992", "3007603826", "3007513035", "3002558692", "3035111606", "3005803793", "2112667", "3022543477", "2020813", "3002808128", "3014579161", "3010157426", "3009129579", "3021559257", "2221819", "1000639866", "3016618143", "3010703925" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }