{ "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": "204295", "product_res_number": "Z-0558-2024", "event_date_initiated": "2023-11-03", "event_date_posted": "2023-12-15", "recall_status": "Open, Classified", "res_event_number": "93416", "product_code": "OWB", "k_numbers": [ "K161563", "K162859", "K200917" ], "product_description": "Philips Allura systems with monoplane fixed ceiling mounts:\n722001 Allura Xper FD10C\n722003 Allura Xper FD10\n722006 Allura Xper FD20\n722010 Allura Xper FD10\n722012 Allura Xper FD20\n722015 Allura Xper FD20 OR Table\n722016 Integris H5000 C / Allura 9C\n722018 Integris Allura 9\n722022 Allura Xper FD10 OR Table\n722023 Allura Xper FD20 OR Table\n722026 Allura Xper FD10\n722028 Allura Xper FD20\n722033 Allura Xper FD10 OR Table\n722035 Allura Xper FD20 OR Table\n722043 Integris Allura 15 & 12 (monoplane)\n72246 Poly G - OMCP - VISUB - CCD (H5000)", "code_info": "Model/Name/UDI-DI:\n722001\tAllura Xper FD10C;\t\n722003\tAllura Xper FD10; \n722006\tAllura Xper FD20\t(01)00884838059115(21);\n722010\tAllura Xper FD10\t(01)00884838059030(21);\n722012\tAllura Xper FD20\t(01)00884838059054(21);\n722015\tAllura Xper FD20 OR Table; \n722016\tIntegris H5000 C / Allura 9C\t; \n722018\tIntegris Allura 9;\t- \n722022\tAllura Xper FD10 OR Table; \n722023\tAllura Xper FD20 OR Table\t(01)00884838059085(21;)\n722026\tAllura Xper FD10\t(01)00884838054189(21);\n722028\tAllura Xper FD20\t(01)00884838054202(21);\n722035\tAllura Xper FD20 OR Table\t(01)00884838054240(21);\n722043\tIntegris Allura 15 & 12 (monoplane).", "firm_fei_number": "3002807880", "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "address_1": "Veenpluis 4-6 4-6 veenpluis", "city": "Best", "country": "Netherlands", "reason_for_recall": "Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose", "root_cause_description": "Device Design", "action": "Philips issued Urgent Medical Device Correction (UMDC) letter US customers in the US on 11/3/23 and a Field Safety Notice (FSN) to customers outside the US. Letter states reason for recall, health risk and action to take:\nAs a remedy, Philips is replacing the existing covers of all the affected Philips Allura and Philips Azurion\nwith the monoplane fixed ceiling mounted systems with a redesigned L-arm rotation cover (bolted\ninstead of spring clips) to make sure it is resistant to external collisions.\nPhilips will contact all affected customers to arrange for a Field Service Engineer visit to replace the Larm\nrotation cover free of charge (reference FCO72200510 for the Philips Allura systems including the\nPhilips Poly G H5000, FCO72200511 for the Philips Azurion systems).\nIf you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).", "product_quantity": "9991 units", "distribution_pattern": "Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, \nAustria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, \nEcuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, \nGermany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, \nHungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan, \nKazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of\nLebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritius, \nMexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, \nNicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, \nParaguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, \nRussian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, \nThailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, \nUzbekistan, Venezuela, Vietnam, Yemen.", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", "K181943", "K130638", "K060259", "K200917", "K070834", "K170752", "K120073", "K103425", "K936180", "K181670", "K030544", "K183144", "K201172", "K041605", "K251199", "K252068", "K190768", "K221281", "K212159", "K243328", "K200022", "K152696", "K212557", "K260607", "K251523", "K142126", "K211191", "K133292", "K961374", "K190064", "K152697", "K923049", "K221335", "K240465", "K252229", "K211782", "K241572", "K921219", "K000221", "K240224", "K160279", "K200887", "K222070", "K183101", "K122234", "K211064", "K111551", "K203281", "K093688", "K082243", "K143225", "K203504", "K181966", "K083725", "K031637", "K223410", "K053279", "K152785", "K243411", "K190626", 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"3013944123", "2939520", "3009144915", "3015223550", "3026391023", "3002808382", "3014279513" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }