{ "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": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222860", "product_res_number": "Z-0199-2027", "event_date_initiated": "2026-09-16", "event_date_posted": "2026-10-16", "recall_status": "Open, Classified", "res_event_number": "99908", "product_code": "MHX", "product_description": "Philips Smart-hopping 2.0 AP 1.4 GHz;\nProduct/Model Number: 867216;", "code_info": "Product/Model Number: 867216;\nUDI-DI: N/A;\nSystem Serial Numbers: DK61624330, DK61623830, DK61724824, DK61623802, DK61623826, DK61624101, DK61624082, DK61623910, DK61624187, DK51313245, DK61724472, DK61724620, DK61724590, DK61724461, DK61724725, DK61724679, DK61724684, DK51313645, DK51313455, DK61724814, DK61724747, DK61624235, DK61422548, DK52316132, DK61724553, DK61724957, DK61724756, DK61523178, DK61724502, DK61724860, DK61523117, DK61724577, DK61724376, DK61724566, DK61422553, DK61322150, DK61523070, DK61523270, DK52617072, DK61523151, DK61422454, DK53817745, DK52617073, DK61422674, DK61422973, DK61523211, DK61322124, DK61523272, DK61523248, DK51313320, DK61422463, DK61523260, DK61322137, DK61322337, DK61322253, DK61322375, DK61322380, DK61422762, DK61422868, DK61322122, DK61422851, DK61322283, DK61523658, DK61422848, DK61422884, DK61422897, DK61523409, DK61422808, DK61422736, DK61422806, DK61422763, DK61523517, DK61422957, DK61523383, DK61523442, DK61322227, DK61422843, DK61523495, DK61423030, DK61422949, DK61322271, DK61322127, DK60621383, DK60621482, DK61322213, DK60321063, DK60320788, DK60621426, DK60621646, DK61322238, DK60621223, DK60621517, DK61322379, DK52316002, DK60320966, DK60621224, DK60621197, DK60821808, DK60621565, DK60821916, DK60821936, DK60320570, DK60320720, DK60320768, DK60320506, DK60320537, DK60321057, DK60320711, DK60320892, DK60320761, DK60320544, DK60321033, DK60320571, DK60320759, DK60320484, DK60321044, DK60320839, DK60320419, DK60320437, DK60320474, DK54820263, DK60320601, DK60320592, DK54820262, DK54820037, DK54819845, DK54820134, DK54819871, DK54820272, DK60320874, DK54519084, DK54519572, DK54820343, DK54819876, DK52516932, DK54519153, DK53817766, DK54518977, DK52516923, DK54519018, DK53817821, DK54820004, DK54819819, DK54820101, DK54819922, DK54518948, DK52516510, DK54519031, DK54518951, DK54519115, DK52516754, DK52516873, DK52516766, DK53817862, DK52516569, DK52516783, DK52516933, DK54418622, DK52516533, DK52315958, DK53217276, DK52316143, DK53217187, DK53217154, DK52316114, DK53217197, DK54418453, DK53918024, DK54418698, DK54418600, DK54418588, DK54418881, DK54519407, DK54418598;", "firm_fei_number": "3006648320", "recalling_firm": "Philips North America", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2296", "additional_info_contact": "Philips Customer Services\n800-722-9377", "reason_for_recall": "Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).", "root_cause_description": "Software design", "action": "On september 16, 2026, URGENT Medical Device Correction, letters were sent to customers.\nActions to be taken:\n1. Direct clinical attendance of the patient during transport, when this issue is most likely to manifest, should be considered if not currently a part of the clinical workflow. In the event a persistent No Central Monit technical alarm is noted at the wireless device or a No Data technical alarm is noted at the central monitor; a restart of the wireless monitor may restore central monitoring when the patient is in known good wireless coverage area.\n2. Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred.\nActions planned by Philips to correct the problem\n3. Philips representative will contact you to arrange the software upgrade SH 2.0 AP 1.4GHz which will correct this issue.\nIf you need any further information, please contact your local Philips representative, or call (800) 722-9377.", "product_quantity": "174", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K172966", "K223574", "K992929", "K022834", "K014261", "K171801", "K073550", "K990068", "K073203", "K153275", "K230604", "K133222", "K012226", "K981576", "K041790", "K030812", "K061993", "K191106", "K150352", "K083697", "K240320", "K202336", "K202405", "K134046", "K142827", "K160685", "K082045", "K001348", "K031320", "K102562", "K024108", "K001722", "K031340", "K100217", "K092449", "K021325", "K043549", "K062194", "K082280", "K121480", "K052756", "K001664", "K200859", "K170876", "K051400", "K013311", "K252840", "K003621", "K223498", "K240312", "K062576", "K130711", "K252250", "K033957", "K152552", "K920445", "K031124", "K041741", "K041607", "K080157", "K014213", "K171580", "K062144", "K183387", "K070566", "K083271", "K221904", "K942700", "K031849", "K190008", "K992674", "K080342", "K011000", "K091395", "K912835", "K182075", "K151027", "K113054", "K191323", "K211619", "K102239", "K052707", "K013199", "K091594", "K133576", "K141015", "K962424", "K191149", "K031403", "K120366", "K000854", "K013427", "K101521", "K023475", "K153448", "K973474", "K945134", "K912188", "K031781", "K100040", "K190939", "K131763", "K062283", "K172226", "K061675", "K161056", "K033711", "K030931", "K060039", "K203088", "K132662", "K123074", "K093501", "K000882", "K944860", "K250349", "K030657", "K000563", "K190011", "K922058", "K032369", "K060541", "K151860", "K051658", "K033365", "K182979", "K881643", "K980411", "K221616", "K012915", "K253170", "K213336", "K112962", "K110622", "K130401", "K023871", "K253277", "K050762", "K051628", "K181831", "K030038", "K143195", "K221879", "K132075", "K040304", "K102422", "K232694", "K254209", "K250179", "K130584", "K002158", "K201941", "K060135", "K100046", "K251508", "K072346", "K213181", "K103134", "K151812", "K220308", "K113657", "K093788", "K921014", "K020531", "K201746", "K030431", "K191249", "K033492", "K001268", "K924575", "K082785", "K150329", "K113798", "K192137", "K023698", "K031760", "K033964", "K980619", "K250854", "K050742", "K911051", "K062271", "K061379", "K151063", "K020290", "K102376", "K120173", "K232962", "K922210", "K021279", "K063690", "K171901", "K023674", "K012016", "K112637", "K141156", "K221056", "K141811", "K061610", "K081983", "K000517", "K231671", "K990563", "K091834", "K121367", "K101449", "K120598", "K081140", "K191769", "K200015", "K031376", "K103652", "K071073", "K210906", "K231477", "K922974", "K120631", "K102004", "K992273", "K031481", "K113623", "K082583", "K872476", "K150082", "K061052", "K971840", "K180482", "K092027", "K260098", "K132077", "K053121", "K151080", "K081891", "K983996", "K993608", "K100939", "K101067", "K192514", "K051217", "K252726", "K993974", "K143676", "K914838", "K043439", "K090556", "K022485", "K101619", "K131414", "K110922", "K123556", "K073462", "K021422", "K213234", "K163584", "K001433", "K923054", "K201764", "K123900", "K160981", "K122146", "K030738", "K173765", "K912627", "K211900", "K950536", "K090702", "K242962", "K041087", "K053484", "K053207", "K132026", "K051367", "K090172", "K122253", "K011540", "K250757", "K950264", "K170567", "K040458", "K041235", "K042642", "K103646", "K982091", "K033600", "K113653", "K113441", "K251702", "K170514", "K132533", "K131223", "K171621", "K053522", "K173036", "K072070", "K030722", "K260343", "K060221", "K030313", "K251146", "K042656", "K252589", "K945099", "K131876", "K102495", "K001693", "K181314", "K970445", "K153160", "K040246", "K120727", "K080495", "K062392", "K022889", "K112190", "K972535", "K260579", "K033694", "K110953", "K041772", "K002209", "K000168", "K023569", "K000815", "K043276", "K992595", "K223531", "K150030", "K944495", "K153702", "K130208", "K073280", "K150975", "K231010", "K180472", "K160951", "K163459", "K081793", "K092369", "K192972", "K180017", "K152973", "K043551", "K092970", "K990476", "K933624", "K063725", "K922668", "K122439", "K203435", "K071164", "K092680", "K062098", "K161517", "K170155", "K060833", "K130849", "K152902", "K090443", "K101692", "K142601", "K063315", "K213799", "K213490", "K913263", "K093268", "K221348", "K003248", "K112803", "K200494", "K071426", "K173768", "K011918", "K013624", "K040357", "K003243", "K131032", "K141963", "K040955", "K131829", "K982279", "K945385", "K030613", "K113045", "K110015", "K113187", "K173454", "K213363", "K083750", "K010923", "K030105", "K123472", "K250453", "K050141", "K131872", "K911646", "K040395", "K120616", "K152407", "K153707", "K061185", "K060281", "K083228", "K033444", "K062324", "K950436", "K030575", "K033304", "K042904", "K002478", "K033048", "K222586", "K070588", "K080251", "K131971", "K131929", "K161531", "K102040", "K172510", "K052801", "K123048", "K071020", "K260656", "K970182", "K032290", "K070791", "K062095", "K242562", "K220989", "K060223", "K011093" ], "registration_number": [ "3008483389", "3043479346", "3015997711", "3007413079", "2080783", "3014263632", "1066270", "3009715978", "3010536822", "3004832480", "3008729547", "3004977335", "2025816", "9610816", "3021736577", "3003591740", "3016674095", "3011120183", "3006979678", "3004035727", "1930027", "3031158", "3010390468", "3006147705", "3007734888", "3016618143", "3010703925", "3000162901", "3012528160", "3021219789", "3013596024", "3007481893", "3012238587", "3006087789", "3014848734", "3022123357", "3000126629", "3008642652", "3007305624", "3013501110", "3008716327", "3008058135", "3010157426", "3003971136", "3007048291", "3008255748", "3010698831", "3019545235", "3017446092", "3005877899", "3003832357", "3011353843", "3020115", "1000122786", "3013314298", "1316463", "9611252", "3015181391", "8030229", "3032109181", "3009443693", "3013500228", "3006606827", "1218950", "2032233", "3009673645", "2221819", "3030516450", "3003589956", "3003263092", "8030978", "3008363989", "9710602", "8022257", "3004526608", "3010882708", "3012421607", "3016931915", "3009077524", "3015328411", "3030597679", "3012359877", "9611031", "3007836437", "3013896610", "3014579161", "3004415095", "3007603826", "3018783526", "3009607734", "3012972516", "3009831876", "3014633893", "3016852448", "3009490946", "3014541700", "9681377", "9610105", "3004196561", "3009499478", "3013557562", "3016701404", "3001570235", "3005521864", "3010552191", "3005783425", "3012104670", "1054713", "3030446844", "1219324", "1000484830", "3005906887", "3023272766", "3009156722", "3013679558", "3009973336", "3021559257", "1651104", "3010611950" ], "fei_number": [ "3008483389", "3043479346", "3015997711", "3007413079", "2080783", "3014263632", "3009715978", "3010536822", "3004832480", "3003142870", "3008729547", "3002808182", "3002807720", "3000215024", "3004977335", "3000957797", "2025816", "3021736577", "3003591740", "3016674095", "3011120183", "3006979678", "1051088", "3003757840", "3004035727", "1930027", "3010390468", "3006147705", "3007734888", "3016618143", "3010703925", "3000162901", "3012528160", "3021219789", "3013596024", "3007481893", "3012238587", "3002806783", "3006087789", "3014848734", "3000126629", "3008642652", "3007305624", "3013501110", "3008716327", "3008058135", "3010157426", "3003971136", "3007048291", "3015191855", "3008255748", "3010698831", "3019545235", "3017446092", "3005877899", "3003832357", "3002807739", "3011353843", "3020115", "1000122786", "1316463", "3002807167", "3015181391", "3032109181", "3009443693", "3013500228", "3006606827", "1218950", "3009673645", "2221819", "3030516450", "1000114111", "3003589956", "3003263092", "3008363989", "3004526608", "3010882708", "3012421607", "3016931915", "3009077524", "3015328411", "3030597679", "3012359877", "3013896610", "3007836437", "3003513129", "1000300598", "3014579161", "3004415095", "3007603826", "3018783526", "3009607734", "3012972516", "3009831876", "3014633893", "3016852448", "3009490946", "3014541700", "3004196561", "3002807019", "3009499478", "3013557562", "3016701404", "3001570235", "3005521864", "3005783425", "3012104670", "3030446844", "1219324", "1000484830", "3005906887", "3023272766", "3009156722", "3013679558", "3010830833", "3009973336", "3021559257", "3010611950", "3002737156" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }