{ "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": "185072", "product_res_number": "Z-0905-2021", "event_date_initiated": "2020-11-02", "event_date_posted": "2021-01-22", "recall_status": "Open, Classified", "res_event_number": "86697", "product_code": "MNT", "k_numbers": [ "K082660" ], "product_description": "Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.", "code_info": "Model: V60\nPart Number: 1053616\nV60 Ventilator, English Opt: None\n\nSerial 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07/29/2021: US Products that Faceplates will be replaced\nModel: V60\nPart Number: 1053616\nV60 Ventilator, English Opt: None\nSerial 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"firm_fei_number": "2518422", "recalling_firm": "Respironics California, LLC", "address_1": "2271 Cosmos Ct", "city": "Carlsbad", "state": "CA", "postal_code": "92011-1517", "additional_info_contact": "800-722-9377", "reason_for_recall": "Potential issues with ventilator navigation ring interface and liquid ingress:\n1) The navigation ring may become inoperative or operate intermittently;\n2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.", "root_cause_description": "Device Design", "action": "On 11/02/2020, the firm sent an \"URGENT-MEDICAL DEVICE CORRECTION\" Notification Letter via priority mail informing customer that the V60 Ventilators may experience two potential issues with the navigation ring interface (see table below for additional information).\n1. The navigation ring may become inoperative or begin operating intermittently.\n2. The navigation ring may not behave as expected, making it difficult for the user to change ventilator settings via the touchscreen.\n\nand if clinicians accept an incorrect setting and leaves the patient on the ventilator without responding to the resulting alarms, the patient could sustain serious injuries.\n\nCustomers are instructed:\n1. When cleaning V60 ventilators, do not allow cleaning agents to pool on the\nventilator surfaces. This is especially important on the device interface.\n2. Check setting changes before and after accepting the changes.\n3. If the navigation ring becomes inoperative or operates intermittently during\nclinical use, use the touchscreen for all settings changes and navigation,\nand contact Philips to schedule service following clinical use.\n4. If the navigation ring interferes with your ability to adjust therapy settings via\ntouchscreen, remove the ventilator from service and contact Philips for\nrepair.\n\nand to please review the following sections of the user manual:\n1. Chapter 10: Care and maintenance. To prevent possible damage to the\nventilator when cleaning, use only those cleaning and disinfecting agents\nlisted, and do not drip or spray any liquids directly onto any ventilator\nsurface.\n2. Chapter 1: Warnings, cautions, and notes. During clinical use of the\nventilator, monitor patients for changes in respiratory status with each\nventilator setting adjustment. Use an external oxygen monitor to verify\noxygen concentration, and have an alternative means of ventilation available\nwhenever a ventilator is in use.\n\nCustomers are also instructed to complete, sign and return the Acknowledgement and Receipt", "product_quantity": "330 systems (Amended on 07/29/2021 - 44,841 U.S. systems for faceplate replacement)", "distribution_pattern": "Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.", "openfda": { "k_number": [ "K990574", "K090113", "K122715", "K982454", "K082660", "K973004", "K071702", "K170367", "K003075", "K053607", "K102985", "K060044", "K951264", "K974539", "K113640", "K103167", "K230173", "K240779", "K213521", "K252182", "K191624", "K242931", "K121623", "K233643", "K955324" ], "registration_number": [ "3033526676", "2221819", "8010042", "3013154126", "3008264065", "3013190994", "3007573469", "3009156722", "3000126629", "3018783526", "3038562397", "2518422", "3023272766", "9617566", "3001400310", "3014631252", "3004604967", "3006783791", "3020283264", "3029227324", "3007603826", "3010817335", "3002797442", "3004428458", "9611451", "3011120183", "2085602" ], "fei_number": [ "3033526676", "2221819", "3013154126", "1000115734", "3008264065", "3013190994", "3009156722", "3000126629", "3018783526", "3038562397", "2518422", "3023272766", "3001400310", "3014631252", "3004604967", "3003244771", "3000210616", "3006783791", "3020283264", "3002808128", "3029227324", "3007603826", "3010817335", "3002797442", "3004428458", "3002806988", "3011120183" ], "device_name": "Sv70 Ventilator", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ] }