{ "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": "218630", "product_res_number": "Z-1557-2026", "event_date_initiated": "2026-01-30", "event_date_posted": "2026-03-11", "recall_status": "Open, Classified", "res_event_number": "98407", "product_code": "MWI", "k_numbers": [ "K160718" ], "product_description": "HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:\nProduct Number:\nVSLBASE03P / VITALSYNCSW03\nModel / UDI-DI codes:\nVital Sync 3.3.1 / 10884521844933\nVital Sync 3.4.0 / 10884521844940\nVital Sync 3.4.1 / 10884521847569 (OUS Only)\nVital Sync 3.4.2 / 10884521856127\n\nProduct Number:\nVSLBASE04P / VITALSYNCSW04\nModel / UDI-DI codes:\nVital Sync 4.0.0 / 10884521849358\nVital Sync 4.0.2 / 10884521856134\n\nThe Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).", "code_info": "HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of:\nCFN: VSLBASE03P / VITALSYNCSW03\nUDI-DI (GTIN); 10884521844933\nSerial Number: Vital Sync 3.3.1\n\nCFN: VSLBASE03P / VITALSYNCSW03\nUDI-DI (GTIN): 10884521844940\nSerial Number: Vital Sync 3.4.0\n\nCFN: VSLBASE03P / VITALSYNCSW03 (OUS only)\nUDI-DI (GTIN): 10884521847569\nSerial Number: Vital Sync 3.4.1\n\nCFN: VSLBASE03P / VITALSYNCSW03\nUDI-DI (GTIN): 10884521856127\nSerial Number: Vital Sync 3.4.2\n\nCFN: VSLBASE04P / VITALSYNCSW04\nUDI-DI (GTIN): 10884521849358\nSerial Number: Vital Sync 4.0.1\n\nCFN: VSLBASE04P / VITALSYNCSW04\nUDI-DI (GTIN): 10884521856134\nSerial Number: Vital Sync 4.0.2", "firm_fei_number": "2936999", "recalling_firm": "Covidien LLC", "address_1": "6135 Gunbarrel Ave", "city": "Boulder", "state": "CO", "postal_code": "80301-3214", "additional_info_contact": "Technical and Clinical Support\n800-255-6774 Ext. 6", "reason_for_recall": "Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.", "root_cause_description": "Under Investigation by firm", "action": "On 01/30/2026, the firm sent via mail or email an \"Urgent Medical Device Correction\" letter to customers informing them that based on a customer report determined that the SpO2 No Pulse Alarm was not transmitted to the Vital Sync\" system as it was not properly configured in the system software. It was further identified that two additional alarms from RespArray\" bedside monitors, CO2 No Breath Detected and RESP No Breath Detected Alarms, were not properly configured in the Vital Sync\" system software. This issue only affects Vital Sync\" remote patient monitoring system used with a RespArray\" bedside monitor.\n\nCustomers are instructed to:\n\"Notify all personnel in all care environments where RespArray\" monitors are connected to Vital Sync\"systems about this safety notice.\n\"Post this notice in a prominent location and ensure awareness of the issue is maintained until the software update is installed.\n\"If further distribution of RespArray\" monitors that are connected to a Vital Sync\" remote monitoring system to other facilities, promptly forward a copy of this letter to those recipients.\n\nPatient Management:\nFor patients currently monitored by a RespArray\" patient monitor and connected to the HealthCast\" Vital Sync\" remote monitoring system as an adjunct for patient monitoring, be advised that the SpO2 No Pulse, CO2 No Breath Detected and RESP No Breath Detected Alarm notifications from the primary RespArray\" patient monitor are not transmitted to the Vital Sync\" remote monitoring system. Refer to Clinical Discovery Guide for specific configurations selected by your facility. No additional action is required by treating clinicians other than recognition that the SpO2 No Pulse, CO2 No Breath Detected and RESP No Breath Detected Alarms are not available to be transmitted from the RespArray\" monitor to the Vital Sync\" remote monitoring system until after the updated software is installed.\n\nFor question - contact Technical and Clinical Support at 800-255-6774, Option 6.", "product_quantity": "78 systems", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.", "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", "K162234", "K032871", "K200160", "K110503", "K003622", "K253196", "K150620", "K170168", "K133394", "K132033", "K070624", "K051518", "K003107", "K130740", "K172965", "K053112", "K101259", 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"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" } } ] }