{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Carlsbad", "state": "CA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "86646", "recalling_firm": "Respironics California, LLC", "address_1": "2271 Cosmos Ct", "address_2": "", "postal_code": "92011-1517", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of 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.", "recall_number": "Z-0890-2021", "product_description": "Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.", "product_quantity": "534 systems", "reason_for_recall": "Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.", "recall_initiation_date": "20201030", "center_classification_date": "20210122", "termination_date": "20240919", "report_date": "20210203", "code_info": "Model: V60 Ventilator, Part Number 1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS Serial Numbers: 100019618 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