{ "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": "159623", "product_res_number": "Z-0082-2018", "event_date_initiated": "2017-08-11", "event_date_created": "2017-11-09", "recall_status": "Terminated", "event_date_terminated": "2024-09-20", "res_event_number": "78465", "product_code": "MWI", "k_numbers": [ "K101571" ], "product_description": "Xper Flex Cardio PhysioMonitoring system \nThe Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.", "code_info": "Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C", "firm_fei_number": "1051786", "recalling_firm": "Invivo Corporation", "address_1": "12151 Research Pkwy Ste 200 12151 Research Pkwy", "address_2": "Ste 200", "city": "Orlando", "state": "FL", "postal_code": "32826-3286", "additional_info_contact": "Contact your Philip representative\n407-275-3220", "reason_for_recall": "Intermittent communication between the host system and the Flex Cardio", "root_cause_description": "Software Design Change", "action": "On August 2017 the firm sent letters to their consignees indicating the following:\nThis document contains important information for the continued safe and proper use of your equipment\n\nPlease review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.\n\nPlease retain a copy with the equipment Instruction for Use.\n-------------------------------------------\nA problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System (Flex Cardio) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you about:\n\n\"\twhat the problem is and under what circumstances it can occur\n\"\tthe actions that should be taken by the customer / user in order to prevent risks for patients or users\n\"\tthe actions planned by Philips to correct the problem.\nBecause of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur:\n\"\tInability of the Flex Cardio to connect to the host system.\n\"\tBoom Monitor (display) may not display all active waveform and/or vital sign data.\n\"\tDelayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor.\n\"\tAfter patient admission and case initiation at the host system, the case may not be fully transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will display vital sign data, but the Flex Cardio will not provide audible alarms.\n\"\tAfter patient discharge and case termination at the host system, case termination may not be transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will continue to display vital sign data, and the Flex Cardio will continue to provide audible alarms.\n\nOur re", "product_quantity": "529", "distribution_pattern": "Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia.", "openfda": { "k_number": [ "K082564", "K131786", "K152341", "K201635", "K022920", "K132807", "K172221", "K150361", "K151715", "K120193", "K102579", "K040559", "K113835", "K233038", "K132808", "K190468", "K082685", "K183370", "K232111", "K233354", "K004050", "K142244", "K153739", "K132604", "K133810", "K142087", "K123002", "K093017", "K122133", "K130796", "K222330", "K210086", "K072516", "K132229", "K053112", "K191059", "K110463", "K003107", "K230881", "K112478", "K082008", "K103737", "K132038", "K103432", "K002030", "K152330", "K124061", "K160718", "K103686", "K233133", "K103268", "K171056", "K142394", "K041401", "K182821", "K031863", "K130411", "K181919", "K060756", "K113833", "K193626", "K253417", "K151839", "K082887", "K001020", "K241958", "K101259", "K063087", "K033988", "K170168", "K161909", "K183634", "K140188", "K211754", "K131497", "K181311", "K172147", "K032867", "K010424", "K142356", "K150620", "K082256", "K143372", "K130740", "K121424", "K130056", "K012349", "K043348", "K022537", "K131762", "K100740", "K083229", "K171121", "K191882", "K243146", "K080173", "K032338", "K200141", "K063055", "K152645", "K170199", "K182401", "K041918", "K100133", "K181541", "K152124", "K013470", "K033133", "K172965", "K220117", "K160956", "K202892", "K200160", "K001265", "K150691", "K033030", "K211475", "K112235", "K142032", "K133394", "K092153", "K240236", "K060712", "K242737", "K072389", "K143304", "K023195", "K071802", "K103763", "K253196", "K021347", "K033378", "K153135", "K140339", "K110503", "K260438", "K121013", "K051896", "K172959", "K134014", "K033680", "K030419", "K133450", "K180903", "K101264", "K033283", "K142732", "K230626", "K020197", "K061590", "K063419", "K140430", "K042981", "K093422", "K102135", "K124038", "K063547", "K190273", "K000635", "K132037", "K001776", "K151512", "K101674", "K033672", "K012094", "K202375", "K133988", "K213335", "K212975", "K131382", "K101127", "K051518", "K153079", "K123711", "K101571", "K071606", "K193242", "K231086", "K191989", "K053462", "K150869", "K121871", "K032749", "K112329", "K013019", "K150512", "K241766", "K021454", "K233810", "K010732", "K133586", "K003999", "K130709", "K082787", "K041376", "K073094", "K000404", "K992638", "K132359", "K063840", "K032871", "K212227", "K130773", "K053027", "K030731", "K041907", "K053234", "K243216", "K071645", "K090785", "K233446", "K021154", "K250135", "K093177", "K021912", "K180734", "K130234", "K010342", "K170032", "K151644", "K170047", "K014181", "K183687", "K162234", "K081552", "K003622", "K142840", "K142106", "K002009", "K061816", "K253436", "K112687", "K122036", "K040915", "K052119", "K171361", "K020022", "K043370", "K202306", "K113105", "K163065", "K101445", "K172200", "K230214", "K160899", "K153225", "K014255", "K221267", "K042569", "K143751", "K170538", "K020494", "K182900", "K070624", "K032142", "K021435", "K060058", "K043368", "K082812", "K130957", "K100424", "K010770", "K120343", "K100394", "K980688", "K101052", "K234130", "K131898", "K051897", "K182226", "K112877", "K151071", "K153335", "K212161", "K183697", "K212473", "K221113", "K071982", "K110516", "K190090", "K230457", "K041942", "K012059", "K010453", "K241411", "K170712", "K183116", "K183638", "K192004", "K071472", "K171751", "K170798", "K102426", "K080141", "K132033", "K113183", "K042560", "K983928", "K113165", "K051608", "K053193", "K210204", "K011578", "K010048", "K200856", "K050399", "K040969", "K002967" ], "registration_number": [ "", "3006546174", "3013896610", "9616760", "3014856521", "3009327812", "3007029079", "1220908", "3006104191", "3009831876", "1058584", "3013298431", "3005521864", "2032233", "3003630387", "3010041430", "3014886121", "3010097171", "3010419931", "9680215", "3024491912", "1051786", "3004009431", "3010399798", "3038259592", "3016701404", "3034603598", "3014128039", "1833920", "3009959868", "3008255748", "3007603826", "3009077524", "3011353843", "3010824458", "2952596", "2080783", "3013501110", "3037341611", "8020045", "3007413079", "2221819", "2011171", "9610816", "2520313", "3007134734", "3009001657", "3018094310", "3009673645", "3006648320", "3009156722", "3016618143", "3010120148", "2936999", "3013500228", "3022425463", "3021343210", "3011359729", "3006240053", "3005803793", "3006606827", "3019834104", "3001570235", "3012103976", "3008729547", "1523530", "3006733253", "9681548", "3013596024", "8030229", "3007481893", "9610105", "3011683100", "8021084", "3010863450", "8043459", "3019388613", "3007305624", "3011200896", "3011651230", "1222630", "3008365372", "3012494290", "3023412068", "3012421607", "1000122786", "9611252", "3021632375", "3020476987", "3004188066", "3000126629", "9710602", "1527715", "3008283443", "8040564", "3043668257", "1316463", "3033959233", "3004906872", "3033715634", "9611348", "3016674095", "3012238587", "1064859", "3012528160", "3008253300", "1066427", "3012359877", "3029871637", "3007836437", "3027256461", "1066270", "3004145393", "3006808382", "8040537", "3003589956", "3003591740", "1221108", "3010317211", "3004091281", "3003294644", "3015529350", "3003832357", "3013557562", "3010157426", "1054713", "3007615597", "3012933969", "3006979678", "3010032903", "3030447506", "2027454", "3004415095", "3010692333", "2183613", "3008977358", "3013188547", "3010120135", "8022257", "3036798186", "3015142815", "8010482", "3010392999", "3042175844", "3008164770", "3008716327", "3016852448", "3032013079", "3002736372", "9615102", "3005569927", "1062836", "3009503584", "3021219789", "3018514222", "3031563234", "3012251275", "3008787503", "1930027", "3000976525", "3016670256", "3003174284", "3009499478", "1651104", "3005053560", "3010390468", "3043543260", "3006146787", "3007137598", "3016931915", "3010716438", "3003971136", "3003681187", "3014579161", "3000130829", "3035111606", "3003768277" ], "fei_number": [ "", "3006546174", "3013896610", "3014856521", "3009327812", "3007513035", "1000219637", "3007029079", "1220908", "3006104191", "3009831876", "3013298431", "3005521864", "3003630387", "3010041430", "3014886121", "3010097171", "3010419931", "3024491912", "1051786", "3004009431", "3010399798", "3038259592", "3016701404", "3034603598", "3014128039", "3009959868", "3002806783", "3003513129", "3008255748", "3006254866", "1000271197", "3007603826", "3009077524", "3011353843", "3000957797", "3010824458", "2080783", "3002807167", "3013501110", "3037341611", "3007413079", "1000114111", "2221819", "2011171", "2520313", "3007134734", "3009001657", "3018094310", "3009673645", "3006648320", "3003757840", "3009156722", "3016618143", "3010120148", "2936999", "3013500228", "3022425463", "1000115656", "3021343210", "3011359729", "3006240053", "3005803793", "3007784465", "3019834104", "3006606827", "3001570235", "3012103976", "3008729547", "1523530", "3006733253", "3013596024", "3007481893", "3011683100", "3010863450", "3019388613", "3007305624", "3004631140", "3002897588", "3011200896", "3011651230", "3008365372", "3012494290", "1000120897", "3023412068", "3012421607", "2995", "1000122786", "3021632375", "3020476987", "3004188066", "3000126629", "3001084824", "1527715", "3008283443", "3000718682", "3043668257", "1316463", "3033959233", "3004906872", "3033715634", "3003142870", "3016674095", "3012238587", "3012528160", "3008253300", "3002737156", "3012359877", "3029871637", "3007836437", "3027256461", "3004145393", "3006808382", "1221108", "3003589956", "3003591740", "3010317211", "3003294644", "3015529350", "3003832357", "3013557562", "3010157426", "3007615597", "3012933969", "3006979678", "3010032903", "3002807720", "3030447506", "2027454", "3004415095", "3010692333", "2183613", "3008977358", "3013188547", "3010120135", "3036798186", "3015142815", "3010392999", "1000292048", "3042175844", "3008164770", "3008716327", "3004117725", "6736", "3016852448", "3002807745", "3032013079", "3005569927", "3002807739", "3009503584", "3021219789", "3002807785", "3002807880", "3018514222", "3031563234", "3012251275", "3008787503", "1930027", "3000976525", "3016670256", "3003174284", "3009499478", "3005053560", "3010390468", "3043543260", "3006146787", "3007137598", "6137", "3016931915", "3010716438", "3003971136", "3003681187", "3014579161", "3000206530", "3000130829", "3005154439", "3035111606" ], "device_name": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2300", "device_class": "2" } } ] }