{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "186883", "product_res_number": "Z-1517-2021", "event_date_initiated": "2021-03-29", "event_date_created": "2021-04-29", "recall_status": "Open, Classified", "res_event_number": "87732", "product_code": "MWI", "k_numbers": [ "K101571" ], "product_description": "Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring\n\nService numbers associated with FC2010:\nXper Flex Cardio 2010 Rev A 453564241901\nXper Flex Cardio 2010 Rev B 453564483321\nFlex Cardio FC2010 Rev C 453564621791\nXper Flex Cardio 2010 REV C RUEXCHANGE 453564675021\nXper Flex Cardio 2010 Rev D 453564669081\nXper Flex Cardio 2010 Rev D Russia 453564674581\nXper Flex Cardio FC2010 Rev E 453564845841\nXper Flex Cardio 2010 Rev E Russia 453564845881\n \nService numbers associated with FC2020:\nXper Flex Cardio 2020 Rev A 453564241911\nXper Flex Cardio 2020 Rev B 453564483331\nFlex Cardio FC2020 Rev C 453564621801\nXper Flex Cardio 2020 Rev D 453564675001\nXper Flex Cardio FC2020 Rev E 453564845861\n\nSoftware version number: 1.5.19 and 1.6.8", "code_info": "Service Number/ UDI # 453564241901 (01)00884838082113; 453564241911 (01)00884838082113; 453564483321 (01)00884838082113; 453564483331 (01)00884838083516; 453564621791 (01)00884838084902; 453564621801 (01)00884838084919; 453564845881 (01)00884838095052; 453564675021 (01)00884838103245; 453564669081 (01)00884838083820; 453564675001 (01)00884838086005; 453564674581 (01)00884838083820; 453564845841 (01)00884838093645; 453564845861 (01)00884838093652", "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": "Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric\nvalues cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform,\nerratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor", "root_cause_description": "Software design", "action": "Philps issued Urgent Field Safety Field Notice-Medical Device Correction to or U.S. customers, the letters were sent via certified mail on 3/29/21.\nPhilips Markets Organizations are responsible for distributing the letters outside of the U.S.\nLetter states reason for recall, health risk and action to take:\nFlex Cardio System.\nBecause the issues listed above can be promptly identified by a qualified health care professional who has reviewed this notice and is closely observing the monitored patient, the Xper Flex Cardio may continue to be used if this step is taken.\nResetting the device as described in the IFU (Section 4, page 87), is likely to\nreturn the device to normal operation, which takes approximately 3-5 minutes.\nTo reset your Flex Cardio device, close any patient cases and then turn the\npower switch off (see back of device for the power switch). Wait 510 seconds\nthen turn the power switch back on. Allow the device to fully restart and\nrestore the monitoring display.\nPlease complete and return the Customer Reply Form included on the last page of this communication indicating your receipt and understanding of this\ninformation.\n\nPhilips will provide a software update for the Xper Flex Cardio to correct all but,\nissue #7 above at no charge. A Philips representative will contact you when the\nsoftware is available for installation.\nPhilips has also added directions to the IFU for the Xper Flex Cardio on how to\nreset the device in the event that the user observes issue #7 above. An IFU\naddendum with the directions will be provided to all affected users when it\nbecomes available.\nIf you need any further information or support concerning this issue, please\ncontact your local Philips representative: 800-669-1328 option 2, then option 3.", "product_quantity": "9208 units WW", "distribution_pattern": "Nationwide\nForeign:\nArgentina\nAustralia\nAustria\nBangladesh\nBelgium\nBulgaria\nCanada\nChile\nChina\nCroatia\nCyprus\nCzech Republic\nDenmark\nDominican Republic\nEcuador\nEgypt\nEstonia\nFinland\nFrance\nGermany\nGreece\nHungary\nIceland\nIndia\nIndonesia\nIran\nIraq\nIreland\nIsrael\nItaly\nJordan\nKazakhstan\nKenya\nKorea, Republic of\nKuwait\nLatvia\nLebanon\nLibya\nLithuania\nMalaysia\nMauritius\nMexico\nMongolia\nMorocco\nMyanmar\nNepal\nNetherlands\nNew Caledonia\nNew Zealand\nNigeria\nNorway\nOman\nPakistan\nPalestine, State of\nPanama\nPeru\nPhilippines\nPoland\nPortugal\nPuerto Rico\nR¿union\nRomania\nRussian Federation\nSaudi Arabia\nSerbia\nSingapore\nSlovenia\nSouth Africa\nSpain\nSri Lanka\nSweden\nSwitzerland\nSyrian Arab Republic\nTaiwan\nThailand\nTunisia\nTurkey\nUnited Arab Emirates\nUnited Kingdom\nUzbekistan\nViet Nam\nYemen", "openfda": { "k_number": [ "K182821", "K152124", "K151071", "K032749", "K170798", "K142244", "K212975", "K250135", "K190468", "K133988", "K143751", "K063087", "K202306", "K100740", "K220117", "K021347", "K071645", "K160718", "K103268", "K101445", "K243216", "K040969", "K212227", "K142032", "K123711", "K132037", "K011578", "K231086", "K051897", "K090785", "K022920", "K150691", "K060058", "K113183", "K061816", "K120343", "K041376", "K063419", "K142732", "K082887", "K020022", "K082008", "K133586", "K150512", "K103432", "K103763", "K020197", "K132229", "K130957", "K131497", "K042981", "K180734", "K120193", "K200856", "K093422", "K212161", "K242737", "K053462", "K110516", "K093017", "K113833", "K010342", "K052119", "K010732", "K031863", "K151644", "K131762", "K041942", "K103686", 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"3002897588", "3003832357", "3009499478", "6137", "3001084824", "3013557562", "3010863450", "3013896610", "6736", "3010120148", "3016852448", "3009156722", "1316463", "3042175844", "3009673645", "3011651230", "3015529350", "3013298431", "3008977358", "3004188066", "3006546174", "3004631140", "2221819", "3013500228", "3010120135", "3010032903", "3010317211", "2936999", "3008716327", "3005154439", "3008787503" ], "device_name": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2300", "device_class": "2" } } ] }