{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "164305", "product_res_number": "Z-2115-2018", "event_date_initiated": "2017-11-20", "event_date_created": "2018-06-07", "recall_status": "Open, Classified", "res_event_number": "80057", "product_code": "MWI", "k_numbers": [ "K101571" ], "product_description": "Xper Flex Cardio Physiomonitoring System\n\nThe Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. 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.", "code_info": "MODEL #(s):  453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375,  US1203010398, US1203010407, US1304000043, US1304000046,  US1224000050, US1550001470, US1251000063, US1109010070,  US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396,  US1231000007, US1231000032, 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US1724000501, US1724000507, US1619002099, US1623002117, US1624002199, US1224000035, US1201010128, US1720000448, and US1224000013", "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": "Philips representative\n800-669-1328 Ext. 2", "reason_for_recall": "While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.", "root_cause_description": "Software design", "action": "The firm, Philips Healthcare, sent an \"URGENT - Medical Device Correction\" letter dated November 2017 and Field Safety Notice to each known affected customer. The letter describes the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The customers were instructed to do the following:\n\nFollow the Action to be Taken by Customer/User section of the Field Safety Notice as follows:\n-You may continue to use the device provided that each monitored patient in the Pre or Post-Op Holding Area is closely observed by a qualified health care professional and is not left unattended, as specified in the devices instructions for use. The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Also, users should always immediately respond to all audible alarms given by the device.\n\nUntil your device can be corrected, please inform users of the content of this notice and instruct them that to properly exit Full Disclosure playback, use the X icon in the upper right corner of the Full Disclosure Playback control window and do not use the ESC key function.\n\nA Philips representative will contact you regarding any affected PCC modules. Each affected PCC will require a software update by Philips. Additionally, all Software and Documentation Media Kits will be replaced. This corrective action will be implemented free of charge by Philips.\n\nIf you need any further information or support concerning this problem, please contact your local Philips representative: 800-669-1328 option 2, then option 3.", "product_quantity": "1,040 units (USA) and 7 units (Foreign)", "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.", "openfda": { "k_number": [ "K220117", "K230881", "K071606", "K040559", "K190468", "K170047", "K051897", "K102135", "K142732", "K150512", "K233038", "K140339", "K001265", "K132359", "K183638", "K163065", "K131382", "K171751", "K170798", "K042569", "K183687", "K022920", "K150620", "K142394", "K101264", "K212975", "K131497", "K052119", "K130773", "K003107", "K123711", "K160718", "K182401", "K151715", "K102426", "K182821", 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