{ "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": 283 } }, "results": [ { "cfres_id": "209981", "product_res_number": "Z-0020-2025", "event_date_initiated": "2023-06-14", "event_date_posted": "2024-10-04", "recall_status": "Open, Classified", "res_event_number": "95324", "product_code": "MHX", "k_numbers": [ "K130849", "K131872" ], "product_description": "IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:\n\n1)\tIntelliVue MX400 \t866060;\n2)\tIntelliVue MX450\t 866062;\n3)\tIntelliVue MX500\t 866064;\n4)\tIntelliVue MX550\t 866066\n \nIndicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.", "code_info": "UDI-DI:\n(01)00884838038769(21);\n(01)00884838038776(21);\n(01)00884838038783(21\n\nSerial Numbers:\nDE7580BB1Y\nDE7580BB1Z\nDE7580BB20\nDE7580BB21\nDE7580BB22\nDE7580BB23\nDE7580BB24\nDE7580BB25\nDE7580BC47\nDE7580BC48\nDE7580BC4L\nDE7580BC4M\nDE7580BC4N\nDE7580BC4P\nDE7580BC4T\nDE7580BC4U\nDE7580BC5K\nDE7580BC5L\nDE7580BC5N\nDE7580BC5P\nDE7580BC5R\nDE7580BC5T\nDE7580BC5U\nDE7580BC5V\nDE7580BC68\nDE7580BC69\nDE7580BC6A\nDE7580BC6B\nDE7580BC6C\nDE7580BC6D\nDE7580BC6E\nDE7580BC6R\nDE7580BC6Z\nDE7580BC8R\nDE7580BCV4\nDE7580BD4K\nDE7580BD4L\nDE7580BF3Z\nDE7580BFUL\nDE7580BFUM\nDE7580BFUN\nDE7580BFWY\nDE7580BJM2\nDE7580BJM3\nDE7580BJM4\nDE7580BJM5\nDE7580BJM6\nDE7580BJM7\nDE7580BJWV\nDE7580BJWW\nDE7580BJWY\nDE7580BJWZ\nDE7580BJY0\nDE7580BJY1\nDE7580BK55\nDE7580BK56\nDE7580BK75\nDE7580BK76\nDE7580BK77\nDE7580BK78\nDE7580BK79\nDE7580BK7A\nDE7580BK7B\nDE7580BK7C\nDE7580BK7D\nDE7580BK7E\nDE7580BC3A\nDE7580BC3B\nDE7580BC3C\nDE7580BC3E\nDE7580BC3F\nDE7580BC3G\nDE7580BC3H\nDE7580BC3J\nDE7580BC3K\nDE7580BC3L\nDE7580BC3M\nDE7580BC3N\nDE7580BC3R\nDE7580BC3T\nDE7580BC3U\nDE7580BC3V\nDE7580BC3W\nDE7580BC3Y\nDE7580BC3Z\nDE7580BC40\nDE7580BC41\nDE7580BC42\nDE7580BC43\nDE7580BC75\nDE7580BC79\nDE7580BCY8\nDE7580BCY9\nDE7580BCYA\nDE7580BCYB\nDE7580BCYD\nDE7580BCYE\nDE7580BCYF\nDE7580BCYG\nDE7580BCYK\nDE7580BCYL\nDE7580BDE4\nDE7580BDE5\nDE7580BDE6\nDE7580BDE7\nDE7580BE0K\nDE7580BE0L\nDE7580BEWY\nDE7580BHZT\nDE7580BNKB\nDE7580BNKC\nDE7580BNKD\nDE7580BNKE\nDE7580BBBA\nDE7580BBUE\nDE7580BBUK\nDE7580BBUL\nDE7580BBUY\nDE7580BBUZ\nDE7580BBV0\nDE7580BBV1\nDE7580BBVC\nDE7580BBVD\nDE7580BBVE\nDE7580BBVF\nDE7580BBVU\nDE7580BBVV\nDE7580BBVY\nDE7580BBW9\nDE7580BBWA\nDE7580BBWB\nDE7580BBWC\nDE7580BBWP\nDE7580BBWR\nDE7580BBYR\nDE7580BC2E\nDE7580BC2F\nDE7580BC2G\nDE7580BC2H\nDE7580BC2M\nDE7580BC2N\nDE7580BC2P\nDE7580BC2R\nDE7580BC2T\nDE7580BC2U\nDE7580BC2V\nDE7580BC2W\nDE7580BC2Y\nDE7580BC2Z\nDE7580BFVB\nDE7580BK89\nDE7580BK8A\nDE7580BK8B", "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": "Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these\ndevices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.", "root_cause_description": "Process control", "action": "PHILIPS issued Urgent Field Safety Notice (2023-CC-HPM-019) on 6/14/23. Letter states reason for recall, health risk and action to take:\n\" Please be aware that without Option C01 (Full Arrhythmia) the device will not provide the\nyellow alarms for enhanced arrhythmia detection.\n\" Review the contents of this letter with your staff.\n\" Pass this notice to all those who need to be aware within your organization or to any organization\nwhere the affected devices might have been transferred.\n5. Actions taken by Philips to correct the problem\nPhilips Representative will contact you to arrange reload of current device's software to enable missing software options (C0l, C13, C51, C54).\nIf you need any further information, please contact your local Philips representative", "product_quantity": "153 units OUS", "distribution_pattern": "Foreign Only: \nDenmark\nFrance\nGermany\nJapan\nUnited Kingdom", "openfda": { "k_number": [ "K014213", "K992273", "K062098", "K050742", "K152902", "K023698", "K173036", "K092369", "K081793", "K043551", "K123472", "K024108", "K130584", "K113657", "K192514", "K221904", "K923054", "K023674", "K033492", "K031320", "K043439", "K022834", "K033444", "K100939", "K252589", "K153160", "K050141", "K070588", "K150975", "K250349", "K170876", "K033694", "K942700", "K030431", "K030105", "K082045", "K061675", "K030038", "K220989", "K062576", "K151063", "K043549", "K250453", "K123074", "K011093", "K981576", "K240320", "K062283", "K251146", "K112803", "K152407", 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"3004035727", "3011353843", "3008255748", "3006147705", "3016674095", "3031158", "3008716327", "3043479346", "3006979678", "3004526608", "3030446844", "3007734888", "3016931915", "9611252", "3009156722", "3009607734", "3010882708", "3008483389", "3004196561", "3017446092", "3009443693", "1219324", "3006606827", "3006087789", "3009831876", "3009715978", "3015181391", "3019388613", "3010536822", "9610816", "3007413079", "3014579161", "3004977335", "3005877899", "3010157426", "3007048291", "3023272766", "3003263092", "3008058135", "9710602", "3012359877", "3016701404", "3003832357", "3012528160", "3013596024", "3012104670", "3014541700", "3007603826", "3032109181", "3013500228", "1000122786", "3004415095", "3030516450", "9610105", "3005521864", "3010703925", "3003971136" ], "fei_number": [ "3003757840", "3030597679", "3009077524", "3003589956", "3002807720", "3001570235", "3020115", "3005783425", "3002807739", "3021219789", "3014848734", "3009499478", "3007305624", "3010698831", 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"3009715978", "3002807167", "3015181391", "3019388613", "3010536822", "3007413079", "3014579161", "3004977335", "3005877899", "3010157426", "3007048291", "3000957797", "3023272766", "3003263092", "3008058135", "3012359877", "3016701404", "3003142870", "3003832357", "3012528160", "3013596024", "3012104670", "3014541700", "3007603826", "3002737156", "3013500228", "3032109181", "1000122786", "3004415095", "3030516450", "3005521864", "3010703925", "3003971136" ], "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }