{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159202", "product_res_number": "Z-0072-2018", "event_date_initiated": "2017-10-11", "event_date_posted": "2017-11-21", "recall_status": "Terminated", "event_date_terminated": "2018-03-12", "res_event_number": "78330", "product_code": "BSZ", "k_numbers": [ "K113051" ], "product_description": "Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G.\n \nThe Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician", "code_info": "UDI: 10841522100017", "firm_fei_number": "3002807992", "recalling_firm": "Spacelabs Healthcare, Ltd.", "address_1": "Foxholes Centre, Unit B unit b foxholes centre john tate road", "city": "Hertford", "country": "United Kingdom", "reason_for_recall": "Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.", "root_cause_description": "Software design", "action": "Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support.", "product_quantity": "110 units", "distribution_pattern": "Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.", "openfda": { "k_number": [ "K170872", "K790456", "K042607", "K770554", "K112114", "K993410", "K032803", "K854213", "K151570", "K921742", "K800801", "K101439", "K122445", "K973896", "K844421", "K903135", "K965160", "K830159", "K120075", "K072884", "K981845", "K000995", "K923519", "K791530", "K103035", "K884879", "K030939", "K945722", "K935546", "K771479", "K971030", "K963481", "K003251", "K903991", "K131945", "K803052", "K191027", "K802591", "K974193", "K171292", "K841370", "K882489", "K760228", "K893780", "K973971", "K083098", "K050626", "K830680", "K033026", "K041622", "K060193", "K071142", "K000706", "K963994", "K850648", "K945234", "K031400", "K853435", "K042419", "K901119", "K251352", "K844849", "K970163", "K853139", "K930492", "K102389", "K844563", "K890410", "K901713", "K132530", "K864590", "K062388", "K051629", "K900329", "K133958", "K011404", "K201957", "K844008", "K971425", "K864806", "K213867", "K973949", "K933285", "K042154", "K252746", "K062155", "K132903", "K864589", "K102471", "K946127", "K983635", "K905635", "K822218", "K001727", "K833335", "K253330", "K980553", "K830161", "K863207", "K945463", "K833147", "K110213", "K884991", "K982137", "K884802", "K050055", "K131790", "K894309", "K081844", "K900937", "K122063", "K902962", "K872178", "K123125", "K864447", "K801100", "K830160", "K003579", "K000859", "K061102", "K052335", "K071097", "K033498", "K230931", "K040743", "K913791", "K771057", "K992421", "K923172", "K001488", "K113633", "K833151", "K080175", "K151954", "K781492", "K801102", "K022031", "K771989", "K092864", "K972848", "K081447", "K930351", "K841274", "K862831", "K061609", "K171311", "K142552", "K003663", "K852175", "K143530", "K172045", "K965041", "K072420", "K140264", "K864644", "K041430", "K042086", "K083413", "K123211", "K973985", "K133886", "K081941", "K801103", "K840356", "K090892", "K901117", "K160665", "K050883", "K934669", "K001315", "K102182", "K073707", "K030624", "K012446", "K920944", "K001988", "K050676", "K861170", "K900328", "K851621", "K862085", "K855022", "K090233", "K844012", "K925580", "K112722", "K981530", "K010613", "K875350" ], "registration_number": [ "", "3022543477", "3003589956", "3014579161", "3005783425", "3010157426", "2221819", "3001104093", "8043316", "3035111606", "3013188547", "9617604", "9710602", "1066270", "3021559257", "9610531", "3009129579", "3009156722", "1054713", "2020813", "9611295", "3016618143", "1530958", "8010042", "2518157", "1066427", "2112667", "1000122786", "3005803793", "3007603826", "3000126629", "3007238566", "3010703925", "9611500" ], "fei_number": [ "", "3022543477", "3002808128", "3003589956", "3002807907", "3014579161", "3005783425", "3010157426", "2221819", "3001104093", "3035111606", "3000957797", "3013188547", "1000639866", "3007513035", "3003513129", "3021559257", "3009129579", "3009156722", "3023530182", "2020813", "3003319165", "3016618143", "3002807992", "2518157", "2112667", "1000122786", "3005803793", "3007603826", "3000126629", "3007238566", "3002558692", "1000114111", "3010703925" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }