{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "132093", "product_res_number": "Z-0374-2016", "event_date_initiated": "2014-12-19", "event_date_posted": "2015-12-04", "recall_status": "Terminated", "event_date_terminated": "2020-09-21", "res_event_number": "70000", "product_code": "MHX", "k_numbers": [ "K102495" ], "product_description": "Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:\n866023 IntelliVue Info Center iX\n866024 PIIC iX Upgrade\n866117 PIIC Classic Upgrade\n\nThe intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. \n\nAn additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.", "code_info": "Software systems Revision A.02.05 or lower", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems, Inc.", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "978-687-1501", "reason_for_recall": "Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification", "root_cause_description": "Software Design Change", "action": "The firm, Philips Healthcare, issued a \"URGENT-Field Safety Notice\" on 12/19/14 to inform customers of the issue, identify details of the units affected, instructs on actions to be taken by the customer and identify what action Philips plans to take to remedy the issue. Philips will provide a software correction free of charge.\nPhilips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice-To prevent this issue from occurring, customers/users should:\n1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from Optional to Hidden\n2) All patient transfers must be performed using the Transfer key in the Manage Patient application.\nRemember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.\n\nIf you need any further information or support concerning this issue, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.", "product_quantity": "10,013 units", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.", "openfda": { "k_number": [ "K191106", "K112190", "K242962", "K122439", "K053121", "K061993", "K051217", "K050742", "K113657", "K103646", "K150329", "K030431", "K191769", "K073203", "K223574", "K033365", "K132533", "K221879", "K240320", "K061379", "K101692", "K992929", "K070566", "K120173", "K213490", "K033694", "K060135", "K053484", "K073280", "K970445", "K232962", "K101067", "K253170", "K945385", "K150030", "K250349", "K123472", "K000517", "K120631", "K922210", "K130584", "K013427", "K043549", "K092970", "K062095", "K000815", "K033600", "K101521", "K052756", "K152407", "K921014", "K092680", "K153702", "K112637", "K052707", "K020290", "K000168", "K023674", "K020531", "K170514", "K102376", "K223531", "K043276", "K000882", "K223498", "K151027", "K002478", "K221616", "K090443", "K100040", "K200494", "K032369", "K170876", "K091395", "K010923", "K201764", "K061052", "K013199", "K163584", "K070588", "K240312", "K210906", "K082583", "K090172", "K021279", "K041607", "K032290", "K161531", "K083228", "K202405", "K110622", "K041772", "K250854", "K213336", "K073550", "K230604", "K983996", "K090556", "K023698", "K113623", "K031781", "K083697", "K141811", "K260098", "K080342", "K981576", "K113798", "K073462", "K222586", "K182075", "K993974", "K031403", "K023475", "K060039", "K203435", "K122146", "K141156", "K030738", "K152973", "K100046", "K982279", "K082045", "K062324", "K022889", "K102562", "K173768", "K071426", "K911646", "K220308", "K001664", "K071020", "K161056", "K001722", "K143676", "K200015", "K101449", "K042656", "K251146", "K102239", "K100939", "K201746", "K093268", "K172226", "K071073", "K182979", "K060833", "K190011", "K000563", "K221904", "K944860", "K041741", "K151080", "K002158", "K131223", "K141963", "K130401", "K001268", "K113653", "K102004", "K003621", "K211619", "K993608", "K123074", "K173765", "K250453", "K970182", "K250179", "K062098", "K063725", "K101619", "K061610", "K031320", "K053207", "K040955", "K120366", "K041790", "K040357", "K103652", "K022485", "K014213", "K130208", "K153448", "K062392", "K962424", "K121367", "K180482", "K040458", "K012915", "K071164", "K031376", "K080251", "K171801", "K052801", "K053522", "K933624", "K080495", "K031340", "K201941", "K161517", "K120616", "K041235", "K113187", "K923054", "K050141", "K971840", "K012226", "K062283", "K070791", "K920445", "K003248", "K131032", "K063315", "K022834", "K990476", "K153160", "K922058", "K031481", "K013624", "K024108", "K141015", "K091594", "K912188", "K942700", "K160981", "K173036", "K050762", "K030313", "K131414", "K040246", "K040304", "K023569", "K221056", "K912627", "K092369", "K990068", "K090702", "K092449", "K113054", "K102040", "K132075", "K914838", "K123556", "K011093", "K160951", "K003243", "K151860", "K132026", "K150082", "K060281", "K131829", "K192137", "K033492", "K990563", "K110015", "K150352", "K250757", "K181314", "K021422", "K023871", "K945099", "K062271", "K082280", "K083271", "K030105", "K171621", "K191249", "K021325", "K881643", "K924575", "K982091", "K033444", "K242562", "K944495", "K014261", "K980411", "K042642", "K131872", "K062144", "K132662", "K950536", "K001348", "K911051", "K183387", "K051628", "K203088", "K211900", "K011000", "K001693", "K231671", "K031760", "K252589", "K992273", "K033711", "K092027", "K012016", "K102495", "K232694", "K002209", "K061675", "K142601", "K142827", "K060223", "K143195", "K973474", "K202336", "K112962", "K172510", "K171901", "K031124", "K042904", "K072070", "K152552", "K051658", "K091834", "K190939", "K950436", "K171580", "K972535", "K030722", "K153707", "K180017", "K181831", "K100217", "K121480", "K030657", "K251702", "K043439", "K123900", "K190008", "K872476", "K134046", "K132077", "K081793", "K180472", "K051400", "K081983", "K030931", "K072346", "K062194", "K001433", "K113045", "K093501", "K191149", "K153275", "K170155", "K011540", "K163459", "K221348", "K191323", "K112803", "K913263", "K000854", "K013311", "K200859", "K231010", "K945134", "K033304", "K060541", "K063690", "K030575", "K912835", "K062576", "K033048", "K060221", "K150975", "K252726", "K192972", "K131929", "K122253", "K130849", "K170567", "K254209", "K093788", "K980619", "K030812", "K151063", "K231477", "K992595", "K152902", "K123048", "K011918", "K213799", "K033964", "K173454", "K081140", "K131763", "K130711", "K251508", "K172966", "K253277", "K051367", "K082785", "K151812", "K252840", "K950264", "K131876", "K043551", "K133576", "K252250", "K213363", "K213234", "K992674", "K160685", "K061185", "K110922", "K131971", "K040395", "K213181", "K922668", "K041087", "K102422", "K110953", "K030038", "K120727", "K120598", "K081891", "K192514", "K113441", "K133222", "K080157", "K030613", "K103134", "K033957", "K083750", "K220989", "K031849", "K922974" ], "registration_number": [ "3013896610", "3030597679", "3006147705", "3009831876", "3008642652", "3004035727", "3005521864", "2032233", "2025816", "3007048291", "3020115", "3031158", "3016701404", "3015328411", "3007734888", "3008255748", "3010611950", "3007603826", "3009077524", "3011353843", "3019545235", "3000162901", "3014541700", "2080783", "3013501110", "3007413079", "2221819", "9610816", "3010536822", "3009673645", "3005783425", "3012104670", "3009156722", "3013314298", "3003263092", "3016618143", "3013500228", "3021559257", "3006606827", "3012972516", "3001570235", "1218950", "3008729547", "3013596024", "8030229", "3007481893", "9610105", "3006087789", "3019388613", "3043479346", "3009973336", "3032109181", "3010552191", "3007305624", "3013679558", "3008483389", "3010703925", "9611031", "1000484830", "3012421607", "3015997711", "3004832480", "1000122786", "3005906887", "9611252", "3022123357", "3000126629", "9710602", "3018783526", "1316463", "3021736577", "3030516450", "3016674095", "3012238587", "3012528160", "3012359877", "3007836437", "3014633893", "1066270", "3003589956", "3009443693", "3003591740", "3009715978", "3008363989", "3004977335", "3008058135", "3013557562", "3010157426", "3003832357", "1054713", "3006979678", "3011120183", "3005877899", "3014848734", "3004196561", "3004415095", "3009607734", "3010698831", "8022257", "3008716327", "1219324", "3016852448", "8030978", "3021219789", "3023272766", "3017446092", "3015181391", "1930027", "3010882708", "3030446844", "3009499478", "1651104", "3010390468", "9681377", "3016931915", "3014263632", "3003971136", "3014579161", "3009490946", "3004526608" ], "fei_number": [ "3013896610", "3030597679", "3006147705", "3009831876", "3008642652", "3004035727", "3005521864", "2025816", "3007048291", "3020115", "3016701404", "3015328411", "3007734888", "3002806783", "3008255748", "3003513129", "3010611950", "3007603826", "3009077524", "3011353843", "3000957797", "3019545235", "3000162901", "3010830833", "3014541700", "2080783", "3002807167", "3013501110", "3007413079", "1000114111", "2221819", "1000300598", "3010536822", "3009673645", "3003757840", "3012104670", "3009156722", "3005783425", "3003263092", "3016618143", "3013500228", "3021559257", "3006606827", "3012972516", "3001570235", "1218950", "3008729547", "3013596024", "3007481893", "3006087789", "3019388613", "3043479346", "3009973336", "3032109181", "3007305624", "3013679558", "3008483389", "3010703925", "1000484830", "3012421607", "3015997711", "3004832480", "1000122786", "3005906887", "3000215024", "3000126629", "3018783526", "1316463", "3021736577", "3030516450", "3003142870", "3016674095", "3012238587", "3012528160", "3002737156", "3012359877", "3007836437", "3014633893", "3002807019", "3003589956", "3009443693", "3003591740", "3002808182", "3009715978", "3008363989", "3004977335", "3015191855", "3008058135", "3013557562", "3010157426", "3003832357", "3006979678", "3002807720", "3011120183", "3005877899", "3014848734", "3004196561", "3004415095", "3009607734", "3010698831", "1051088", "3008716327", "1219324", "3016852448", "3002807739", "3021219789", "3023272766", "3017446092", "3015181391", "1930027", "3010882708", "3030446844", "3009499478", "3010390468", "3016931915", "3014263632", "3003971136", "3014579161", "3009490946", "3004526608" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }