{ "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": "217179", "product_res_number": "Z-0865-2026", "event_date_initiated": "2025-10-31", "event_date_posted": "2025-12-02", "recall_status": "Open, Classified", "res_event_number": "97917", "product_code": "MHX", "k_numbers": [ "K131872" ], "product_description": "IntelliVue Patient Monitor MX550. Product Number: 866066.", "code_info": "Product Number: 866066; UDI-DI: 00884838038783; All Serial No.", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Philips Customer Service\n800-722-9377", "reason_for_recall": "Potential issue where the IntelliVue monitors did not alarm.", "root_cause_description": "Use error", "action": "An URGENT Medical Device Correction notice, dated 10/31/25, was mailed to customers and distributors. \n\nDistributors were notified of this correction and instructed to forward the provided recall notification to all consignees. Additionally, distributors are asked to include their contact information for consignees in the provided response form and perform a good faith effort for each customer to obtain a completed response form. \n\nConsignees are instructed to notify all users of this recall notification and forward the notice to all who need to be aware within their organization or where affected devices were potentially transferred. Consignees are to re-evaluate and reconfigure device configuration per the provided instructions. Once recall actions have been completed, consignees are to complete the provided response form either via QR code, by email to Recall.Response@philips.com, or by fax to 877-499-7223.\n\nPhilips is planning to develop a software update which will enforce the additional confirmation step when the user enables infinite Alarms Off for IntelliVue MP5 models only. \n\nConsignees with any questions can contact Philips at 800-722-9377.", "product_quantity": "1,913,441 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Botswana, Brazil, Brunei, Bulgaria, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Equat Guinea, Estonia, Ethiopia, Faroe Islands, Finland, French Polynesia, France, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea Rep, Kuwait, Lao, Latvia, Lebanon, Lesotho, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Ant, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, , R¿union, Romania, Russia, Saint Vincent, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre Mqln, Suriname, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Tajikistan, Thailand, Trinidad Tobago, Tunisia, T¿rkiye, Turkmenistan, Uganda, Ukraine, United Kingdom, United States, Uruguay, Utd Arab Emir, Uzbekistan, Venezuela, Viet Nam, Virgin Isl (Br), Virgin Isl (US), White Russia, Yemen, Zambia, Zimbabwe.", "openfda": { "k_number": [ "K191106", "K112190", "K242962", "K122439", "K053121", "K061993", "K051217", "K050742", "K113657", "K103646", "K150329", "K030431", "K191769", "K073203", "K223574", "K033365", "K132533", "K221879", "K240320", "K061379", "K101692", "K992929", "K070566", "K120173", "K213490", "K033694", "K060135", "K053484", "K073280", "K970445", "K232962", "K101067", "K253170", "K945385", "K150030", "K250349", "K123472", "K000517", "K120631", "K922210", "K130584", "K013427", "K043549", "K092970", "K062095", "K000815", "K033600", "K101521", "K052756", "K152407", "K921014", "K092680", "K153702", "K112637", "K052707", "K020290", "K000168", "K023674", "K020531", "K170514", "K102376", "K223531", "K043276", "K000882", "K223498", "K151027", "K002478", "K221616", "K090443", "K100040", "K200494", "K032369", "K170876", "K091395", 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