{ "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": "159835", "product_res_number": "Z-0263-2018", "event_date_initiated": "2017-08-18", "event_date_created": "2017-12-19", "recall_status": "Terminated", "event_date_terminated": "2024-09-20", "res_event_number": "78585", "product_code": "MWI", "k_numbers": [ "K101571" ], "product_description": "Xper Flex Cardio Physiomonitoring system.\n\nUsed to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.", "code_info": "All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338", "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": "Your Local Philips Representative\n407-275-3220", "reason_for_recall": "Intermittent communication between the host system and the FlexCardio", "root_cause_description": "Software Design Change", "action": "On August 24, 2017 Philips send the following communications to distributors and clients.\nDear Distributor,\n\nPhilips is initiating an action related to the Xper Flex Cardio Patient Monitoring System.\n\nThe attached Field Safety Notice is intended to inform customers 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, users or servicers\n\"\tthe actions planned by Philips to correct the problem.\n\nIt is imperative that all affected end users of the Xper Flex Cardio receive the attached Field Safety Notice. Because Philips sells these products through distributors, including your organization, we may not have the information necessary to contact all end users. Therefore, please send the attached Field Safety Notice to each customer to whom you have distributed one of the affected devices. A description of the affected device can be found in the Field Safety Notice attached.\n--\nDear Customer,\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, which could result in delays in diagnosis or treatment:\n\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 ca", "product_quantity": "4,535", "distribution_pattern": "AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico\nAlgeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen", "openfda": { "k_number": [ "K082564", "K131786", "K152341", "K201635", 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