{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221407", "product_res_number": "Z-2955-2026", "event_date_initiated": "2026-07-01", "event_date_posted": "2026-08-14", "recall_status": "Open, Classified", "res_event_number": "99361", "product_code": "DPS", "k_numbers": [ "K241556" ], "product_description": "Cardiac Workstation 5000. Product Number: 860439.", "code_info": "Product Number: 860439. UDI: (01)00884838094826. Serial Numbers: US42510185, US42510184, US52510209, US52510200, US52510226, US52510228, US62510247, US62510250, US62510256, US72510286, US82510299, US82510307, US82510300, US82510313, US82510318, US82510314, US82510335, US82510336, US82510341, US82510325, US92510351, US92510353, US92510354, US92510361, US92510362, US92510370, USN2510413, USN2510414, USN2510434, USN2510435, USN2510437, USD2510506, USD2510519, US12610582, USD2510513, US12610598, US22610609, US22610683, US22610691, US22610689, US32610737, US32610744, US32610759, US32610766, US32610749, US32610739, US32610751, USD2510516, USD2510510, USD2510517, USD2510529, USD2510509, US32610752, US32610753, US32610879, US32610880, US32610901, US32610914, US42610946, US32610915, US32610941, US32610932, US42610943, US42610942, US42610959, US42610958, US42610955, US42610974, US42610967, US42610956, US42610993, US42610960, CN72410032, CN92410061, CNO2410064, CNO2410068, CNN2410075, CND2410080, CND2410101, CND2410103, CN12510116, CN12510136, CN22510140, CN22510142, CN22510146, CN32510148, CN32510161, CN42510168, CN42510181, CN42510183, CN52510204, CN52510201, CN52510217, CN62510239, CN62510241, CN62510242, CN62510253, CN62510254, CN62510251, CN72510275, CN72510282, CN72510281, CN72510285, CN72510289, CN72510288, CN72510293, CN72510297, CN82510305, CN82510310, CN82510323, CN82510324, CN82510321, CN92510343, CN92510364, CN92510365, CN92510367, CN92510374, CNO2510380, CNO2510392, CNO2510383, CNO2510386, CNO2510396, CNN2510412, CNN2510410, CNN2510427, CNN2510443, CNN2510444, CNN2510454, CNN2510485, CNN2510486, CND2510503, CND2510502, CND2510508, CND2510528, CND2510530, CND2510566, CND2510575, CND2510574, CN12610585, CN12610590, CN12610595, CN12610593, CN22610612, CN22610681, CN22610707, CN22610735, CN32610755, CN32610760, CN32610761, CN32610762, CN32610763, CN32610765, CN32610818, CN32610826, CN32610910, CN32610913, CN32610912, CN32610924, CN32610923, CN32610929, CN32610930, CN32610933, CN42610944, CN42610951, CN42610970, US42610994", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Philips Customer Services\n800-722-9377", "reason_for_recall": "Device will intermittently provide inaccurate data related to native heart rate.", "root_cause_description": "Software design", "action": "Philips notified consignees on about 07/01/2026 via URGENT Medical Device Correction letter. Consignees were informed that they could continue the use of the device but to refer to the information within the notification letter, disable the automatic Standby feature on the Cardiac Workstation and avoid manually putting the Cardiac Workstation in Standby mode to minimize the inaccurate heart rate value from occurring, and to pass the notice to all those who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Additionally, consignees were requested to place the Urgent Medical Device Correction letter with the documentation of the Cardiac Workstation and associated devices in a place where it is most likely to be seen and viewed. \n\nPhilips representatives will contact consignees to arrange an upgrade to the Cardiac Workstation Release 1.2.0.7.", "product_quantity": "796 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ "K832212", "K020708", "K001034", "K961401", "K882472", "K170995", "K212112", "K831878", "K823220", "K991786", "K092576", "K240229", "K852281", "K052049", "K860734", "K864009", "K873346", "K883402", "K872658", "K230834", "K897121", "K871993", "K061123", "K232161", "K896417", "K101867", "K002459", "K032200", "K861851", "K060766", "K760465", "K001896", "K160667", "K120770", "K955642", "K102378", "K822582", "K180242", "K082312", "K852770", "K914762", "K230812", "K050686", "K844470", "K090212", "K823281", "K193415", "K822768", "K120865", "K052303", "K043074", "K151135", "K890791", "K170568", "K882198", "K874326", "K052295", "K012263", "K152384", "K091397", "K862748", "K850021", "K760272", "K955113", "K020366", "K884116", "K900700", "K760265", "K130921", "K013615", "K860175", "K152427", "K103640", "K160746", "K810263", "K951128", "K103077", "K010505", "K221141", "K864704", "K884992", "K191692", "K210560", "K914725", "K024278", "K163607", "K920020", "K042814", "K930558", "K882254", "K915879", "K860646", "K832050", "K210140", "K232974", "K180234", "K141582", "K142105", "K953415", "K960321", "K101403", "K830791", "K790739", "K082946", "K840571", "K902368", "K043380", "K150564", "K942629", "K082709", "K960449", "K800593", "K890481", "K972199", "K861359", "K813021", "K883468", "K131819", "K012264", "K760854", "K823488", "K860212", "K002074", "K172778", "K935394", "K110328", "K051534", "K801677", "K250569", "K864978", "K091358", "K760677", "K090936", "K111601", "K090367", "K070614", "K832130", "K823529", "K243305", "K243252", "K832013", "K093872", "K862381", "K884662", "K803309", "K972310", "K971038", "K832227", "K903671", "K171517", "K014262", "K790300", "K770832", "K102767", "K103765", "K933065", "K173830", "K862951", "K912183", "K811949", "K833593", "K950779", "K100813", "K880357", "K131262", "K821758", "K083715", "K974746", "K863535", "K220362", "K790939", "K964784", "K050858", "K110266", "K900598", "K954066", "K072353", "K131573", "K860636", "K131900", "K833470", "K881328", "K883454", "K112959", "K854234", "K972603", "K914206", "K981807", "K863116", "K221260", "K152135", "K791540", "K904758", "K864504", "K010822", "K082173", "K101876", "K152043", "K760150", "K884956", "K000645", "K904606", "K171360", "K183369", "K922927", "K102854", "K981697", "K160876", "K922291", "K072449", "K201456", "K811341", "K831429", "K861067", "K191738", "K921930", "K081437", "K770037", "K770760", "K780138", "K896064", "K852829", "K122073", "K093339", "K863100", "K961247", "K946205", "K042827", "K896190", "K811950", "K070539", "K152944", "K993414", "K950004", "K864700", "K031182", "K102206", "K170154", "K863652", "K863030", "K223013", "K872548", "K060167", "K093869", "K881055", "K961798", "K844744", "K131503", "K810104", "K813022", "K833584", "K840440", "K860790", "K071168", "K945626", "K851044", "K252361", "K013367", "K791364", "K121825", "K820067", "K832184", "K923221", "K042177", "K791201", "K050674", "K844101", "K892835", "K972991", "K955045", "K930134", "K881939", "K760271", "K934439", "K851322", "K203786", "K823584", "K821090", "K964408", "K143436", "K133985", "K770366", "K893660", "K223670", "K101115", "K832888", "K002822", "K913374", "K121009", "K173952", "K120188", "K033488", "K031422", "K011436", "K832883", "K013565", "K852322", "K813279", "K002473", "K882197", "K863914", "K851662", "K842944", "K802718", "K800566", "K802190", "K760542", "K901947", "K972996", "K841611", "K901817", "K131572", "K973437", "K132758", "K092010", "K143432", "K123217", "K131858", "K855096", "K050620", "K800005", "K173226", "K802368", "K130409", "K113485", "K903524", "K142551", "K011177", "K981951", "K220535", "K122632", "K851643", "K864580", "K113144", "K112622", "K760612", "K232445", "K012414", "K062068", "K062894", "K820011", "K780166", "K771380", "K933404", "K103427", "K152863", "K870380", "K760268", "K933156", "K832014", "K053083", "K896772", "K170182", "K232823", "K072217", "K864614", "K760926", "K222902", "K901032", "K111805", "K761023", "K901948", "K840569", "K003392", "K843934", "K910017", "K232512", "K760266", "K924544", "K093172", "K232035", "K810154", "K792072", "K923406", "K070136", "K233266", "K897029", "K850702", "K062469", "K901771", "K080933", "K012686", "K231150", "K024283", "K914974", "K790114", "K903722", "K101569", "K830666", "K082013", "K974351", "K861992", "K080999", "K760463", "K021230", "K182790", "K781679", "K062282", "K873584", "K791151", "K941811", "K171942", "K080036", "K850323", "K791420", "K130207", "K761198", "K182093", "K080884", "K091513", "K062677", "K221321", "K252474", "K051126", "K162665", "K862544", "K885177", "K875057", "K183425", "K052511", "K142288", "K800004", "K974220", "K833951", "K790233", "K100127", "K073625", "K811016", "K972746", "K963198", "K861281", "K950018", "K865031", "K072060", "K172068", "K112135", "K001492", "K182571", "K841148", "K860249", "K200036", "K093211", "K790794", "K200884", "K884800", "K082380", "K002197", "K032145", "K113234", "K800659", "K810357", "K052898", "K851633", "K830566", "K252463", "K081473", "K212278", "K844392", "K884896", "K832015", "K022149", "K031557", "K800492", "K111159", "K132068", "K050074", "K955416", "K880595", "K111438", "K790869", "K183322", "K854840", "K141946", "K022618", "K231160", "K991831", "K122712", "K970787", "K871239", "K890875", "K874641", "K781054", "K840869", "K241217", "K832421", "K051163", "K852282", "K142969", "K140020", "K241556", "K013564", "K952173", "K181998", "K110065", "K123816", "K792229", "K950989", "K973426", "K090483", "K993875", "K021171", "K810696", "K870880", "K915760", "K802952", "K864465", "K040313", "K171943", "K232816", "K760510", "K101016", "K955546", "K810988", "K864843", "K840020", "K790691", "K833458", "K900272", "K133622", "K092663", "K122356", "K963578", "K820014", "K884504", "K012540", "K862553", "K921331", "K850454", "K860973", "K090249", "K112431", "K013717", "K870926", "K030535", "K922703", "K160092", "K963400", "K883903", "K881475", "K811121", "K904355", "K251670", "K170954", "K850322", "K010955", "K896386", "K212163", "K113306", "K810176", "K894956", "K920364", "K955891", "K780307", "K943709", "K082967", "K010758", "K022152", "K980362", "K974079", "K160840", "K082124", "K903774", "K142693", "K861850", "K761014", "K791421", "K103791", "K841254", "K102830", "K161302", "K853979", "K852181", "K791795", "K802113", "K030104", "K821888" ], "registration_number": [ "3008483389", "3030154814", "3014541700", "3021559257", "3018587883", "3004415095", "3013298431", "8030245", "8030978", "1054713", "3013250653", "3013757696", "3010536822", "3003294644", "3013679558", "3008457078", "3043479346", "3007734888", "3003681187", "3003832357", "3013689228", "9611031", "3013896610", "3010838917", "3003647588", "9610105", "1219324", "3008716327", "3005521864", "3009715978", "3013188547", "1218950", "3031158", "9611295", "1651104", "3010419931", "3007413079", "2080783", "3011721071", "3021422553", "3008642652", "3014522540", "3036039911", "3004145393", "2000004234", "3042928308", "3010381606", "3011200896", "3018783526", "3016852448", "3013596024", "3001570235", "3033558564", "3007836437", "3033959233", "3023146633", "8030229", "3009443693", "3003857828", "3000130829", "3013557562", "3030125003", "3041276591", "3012421607", "3012516456", "3012250536", "3016701404", "2182208", "3014579161", "3023272766", "3010089768", "3043668257", "3011235999", "3008921101", "3015134086", "3008881835", "3012494290", "3007048291", "1314417", "3009607734", "3032109181", "3043226252", "1066427", "3007029079", "3012302888", "3007305624", "3023412068", "1450057", "3005488716", "9611252", "1319390", "3011359729", "3011651230", "3030447506", "3010342616", "3003263092", "3003591740", "3009183442", "3005569927", "3033536319", "1930027", "8030673", "3003622639", "3020981894", "3004582233", "3030733800", "3011353843", "3012404027", "1220477", "3034603279", "3035371769", "3012027770", "3001373226", "3038259592", "1316463", "3029871637", "1000122786", "3007384703", "3007134734", "3004035727", "3010082909", "3014848734", "3010698831", "3008717264", "3009499478", "3003971136", "3016674095", "2084041", "3010390468", "3010157426", "9617277", "3007770164", "3007184699", "9680510", "3003174284", "3031570367", "9611045", "3004906872", "9710602", "3000126629", "3004186703", "3045323923", "3012528160", "9615102", "3005783425", "3009735945", "3005877899", "1220908", "3016618143", "3030446844", "3006087789", "1126271", "3021131596", "3009077524", "3030639099", "3013501110", "2433214", "3009831876", "1523530", "3008164770", "9610816", "3013500228", "3032536454", "3008729547", "3006371704", "3010097171", "3019388613", "3016931915", "3014449259", "3006979678", "3008293988", "3015142815", "3031786139", "3030597723", "3008820594", "3012359877", "1066270", "3008505660", "3001149827", "3011861727", "3018094310", "3045498928" ], "fei_number": [ "3008483389", "3030154814", "3014541700", "3021559257", "1000271197", "3018587883", "3004415095", "3013298431", "3002807019", "3013250653", "3013757696", "3010536822", "3003294644", "3013679558", "3008457078", "3043479346", "3007734888", "3003681187", "3003832357", "3013689228", "3013896610", "3004213967", "3010838917", "3003647588", "1219324", "3008716327", "3005521864", "3009715978", "3013188547", "1218950", "3010419931", "3007413079", "2080783", "3011721071", "3021422553", "3008642652", "3014522540", "3036039911", "3004145393", "2000004234", "3042928308", "3010381606", "3011200896", "3018783526", "3016852448", "3013596024", "3007513035", "3001570235", "3033558564", "3007836437", "3003513129", "3033959233", "3023146633", "3009443693", "3003857828", "3000130829", "3002807167", "3013557562", "3030125003", "3041276591", "3000957797", "3012421607", "3012516456", "3012250536", "3016701404", "2182208", "3014579161", "3023272766", "3002807674", "3010089768", "3043668257", "3003190524", "3011235999", "3008921101", "3015134086", "3008881835", "3012494290", "3007048291", "1314417", "3009607734", "3032109181", "3043226252", "3007029079", "3012302888", "1000263641", "3007305624", "3023412068", "1450057", "3005488716", "1319390", "3011359729", "3011651230", "3000215024", "3030447506", "3010342616", "3003263092", "3003591740", "3009183442", "3005569927", "3033536319", "1930027", "3003622639", "3020981894", "3004582233", "3030733800", "3011353843", "3012404027", "1220477", "3034603279", "3035371769", "3012027770", "3001373226", "3038259592", "3002808182", "1316463", "3029871637", "1000122786", "3002807720", "3007384703", "3007134734", "3004035727", "3010082909", "3014848734", "3010698831", "3008717264", "3009499478", "3003971136", "3016674095", "2084041", "3010390468", "3010157426", "3003708031", "1000114111", "3007184699", "3007770164", "3003174284", "3031570367", "3004906872", "3000126629", "3004186703", "3002807992", "3045323923", "3012528160", "3005783425", "3009735945", "3002807739", "3005877899", "1220908", "3016618143", "3030446844", "3006087789", "3021131596", "3009077524", "3030639099", "3013501110", "2433214", "3009831876", "1523530", "3008164770", "3013500228", "3032536454", "3008729547", "3004072282", "3006371704", "3010097171", "3019388613", "3016931915", "3014449259", "3002806783", "3006979678", "3008293988", "3015142815", "3031786139", "3002737156", "3030597723", "3008820594", "3012359877", "3008505660", "3001149827", "3011861727", "3018094310", "3045498928" ], "device_name": "Electrocardiograph", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2340", "device_class": "2" } } ] }