{ "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": "159598", "product_res_number": "Z-0496-2018", "event_date_initiated": "2017-10-02", "event_date_posted": "2018-01-16", "recall_status": "Terminated", "event_date_terminated": "2020-12-14", "res_event_number": "78442", "product_code": "DQK", "k_numbers": [ "K163381" ], "product_description": "Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). \n\nProduct Usage:\nThe HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).", "code_info": "HEM1 UDI 00690103197006 (Serial No. 13800180, 13800185, 13800193, 13800195, 13800228, 13800162, 13800168, 13800171, 13800208, 13800210, 13800211, 13800126, 13800128, 13800129, 13800130, 13800132, 13800133, 13800135, 13800139, 13800140, 13800144, 13800146, 13800147, 13800148, 13800150, 13800187, 13800189, 13800131, 13800134, 13800136, 13800191, 13800192, 13800197, 13800172, 13800173, 13800159, 13800184, 13800188, 13800339, 13800355, 13800199, 13800200, 13800141, 13800249, 13800258, 13800259, 13800260, 13800263, 13800265, 13800268, 13800270, 13800176, 13800177, 13800179, 13800186, 13800225, 13800227, 13800230, 13800196, 13800124, 13800125, 13800137, 13800138, 13800142, 13800143, 13800145, 13800149, 13800151, 13800152); HEMSGM10 UDI 00690103196993 (Serial No. 13600223, 13600224, 13600225, 13600226, 13600257, 13600196,  13600197, 13600198, 13600227, 13600228, 13600229, 13600158, 13600159, 13600160, 13600161, 13600162, 13600163, 13600164, 13600165, 13600166, 13600167, 13600168, 13600169, 13600170, 13600171, 13600206, 13600207, 13600145, 13600146, 13600147, 13600208, 13600209, 13600211, 13600199, 13600201, 13600193, 13600194, 13600195, 13600390, 13600421, 13600212, 13600213, 13600202, 13600203, 13600204, 13600205, 13600255, 13600256, 13600258, 13600210, 13600148, 13600149, 13600150, 13600151 13600152, 13600153, 13600154, 13600155, 13600156, 13600157); HEMOXSC100 UDI 00690103196986 (Serial No. 13700241, 13700246, 13700247, 13700248, 13700303, 13700188, 13700189, 13700190, 13700280, 13700282, 13700291, 13700149, 13700150, 13700151, 13700152, 13700153, 13700154, 13700155, 13700156, 13700157, 13700158, 13700159, 13700160, 13700161, 13700162, 13700174, 13700177, 13700136, 13700137, 13700138, 13700179, 13700199, 13700182, 13700191, 13700192, 13700193, 13700194, 13700180, 13700185, 13700186, 13700183, 13700187, 13700201, 13700205, 13700215, 13700236, 13700240, 13700258, 13700265, 13700270, 13700271, 13700195, 13700196, 13700197, 13700198, 13700252, 13700301, 13700363, 13700175, 13700139, 13700140, 13700141, 13700142, 13700143, 13700144, 13700145, 13700146, 13700147, 13700148)", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "949-250-6827", "reason_for_recall": "Pre-procedural issues related to software defects", "root_cause_description": "Device Design", "action": "Consignees were sent recall notification letters on approximately 10/11/2017. The letter identified the affected product, problem and actions to be taken. instructions included coordination with the respective Edwards representative to schedule the software upgrade.", "product_quantity": "198 devices", "distribution_pattern": "US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX", "openfda": { "k_number": [ "K220243", "K042681", "K190106", "K202066", "K260212", "K061905", "K210392", "K242133", "K242016", "K950723", "K051471", "K792525", "K223918", "K261119", "K990727", "K170600", "K252859", "K871436", "K093942", "K121638", "K233853", "K973751", "K022596", "K935186", "K210680", "K992948", "K212061", "K141050", "K212345", "K230008", "K860854", "K152881", "K142901", "K151245", "K042628", "K161465", "K930639", "K023370", "K945068", "K213409", "K913193", "K042463", "K093092", "K222389", "K810750", "K242129", "K000332", "K103678", "K180881", "K061741", "K812739", "K251344", "K252429", "K253576", "K123984", "K223812", "K001305", 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"3021769057", "3010390468", "3010716438", "3003971136", "3014579161", "3012520654", "3009254201", "3000206530", "3002672225", "3001451571", "3015151147" ], "device_name": "Computer, Diagnostic, Programmable", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1425", "device_class": "2" } } ] }