{ "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": 16 } }, "results": [ { "cfres_id": "217626", "product_res_number": "Z-1062-2026", "event_date_initiated": "2025-12-15", "event_date_posted": "2026-01-13", "recall_status": "Open, Classified", "res_event_number": "98109", "product_code": "OWB", "k_numbers": [ "K102005", "K130638", "K130842", "K133292", "K141979", "K161563" ], "product_description": "Product Name: Allura Xper FD10C;\nModel number: 722001;", "code_info": "Model Number: 722001;\nSystem Product Name: Allura Xper FD10C;\nUDI-DI: N/A;\nSerial Numbers: 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, 299, 30, 235, 221, 348, 283, 276, 253, 1100, 78, 229, 232, 159, 177, 219, 217, 205, 3, 89, 101, 295, 305;", "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": "Philips has identified that in a limited number of impacted systems the drip tray\nbeneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately\ndocumented. If it is not installed, there is a potential for coolant liquid to contact electrical\ncomponents. This could lead to electrical short-circuits, which may trigger system fuses and result in\nsystem shutdown.", "root_cause_description": "Other", "action": "On December 15, 2025, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: \na.\tAffected systems may continue to be used in accordance with their Instructions for Use (IFU). \nb.\tCirculate this letter to all users so that they are aware of the issue. Keep this letter with the documentation of the system until Philips inspects and, where needed, corrects your system.\nc.\tEstablish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure.\nd.\tIf you detect a burning odor, smoke, or fire originating from the R-cabinet in the technical room, immediately switch off the system s main power. Do not operate or use the system further. Follow your institution s emergency procedures.\ne.\tIn case the affected system has been transferred to another organization, please send a copy of this letter to that organization and inform Philips about this transfer through your local Philips representative.\nf.\tComplete and return the attached response form to Philips promptly and no later than 30 days from receipt. \ng.\tShould you experience the issue reported in this letter, please report the event to Philips through your local Philips representative.", "product_quantity": "38 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "openfda": { "k_number": [ "K202360", "K260607", "K222080", "K123226", "K251199", "K222998", "K041931", "K202547", "K122644", "K073543", "K220432", "K251827", "K211780", "K022069", "K912448", "K982993", "K101868", "K161839", "K091918", "K070834", "K152697", "K160279", "K231700", "K132970", "K230950", "K243884", "K130638", "K233200", "K052412", "K161563", "K111551", "K153232", "K210054", "K252500", "K152785", "K251992", "K102529", "K122457", "K151904", "K113027", "K172307", "K143281", "K241572", "K220311", "K082781", "K960920", "K123529", "K182415", "K151000", "K212159", "K120073", "K253726", "K052202", "K041932", "K211191", "K251893", "K212523", "K141574", "K212557", "K140041", "K221230", "K192182", "K240224", "K152696", "K191503", "K252099", "K210309", "K252068", "K193230", "K982427", "K181415", 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"K042053", "K171194", "K160147", "K211064", "K032046", "K201743", "K120282", "K133580", "K142740", "K212336", "K173631", "K252503", "K231669", "K103425", "K130893", "K050489", "K142243", "K153147", "K220409", "K213768", "K230185", "K173639", "K081073", "K250660", "K203535", "K062647", "K100102", "K102005", "K092438", "K172822", "K103416", "K093066", "K983069", "K200022", "K251520", "K220946", "K142126", "K021049", "K200887", "K211782", "K993687", "K051064", "K083725", "K210912", "K221281", "K223409", "K182086", "K181670", "K162148", "K243376", "K213479", "K181560", "K132027", "K210900", "K163140", "K203281", "K212383", "K961374", "K163286", "K211777", "K142273", "K212813", "K232420", "K151598", "K160088", "K113403", "K133278", "K061534", "K022114", "K961105", "K061163", "K033244", "K173664", "K061203", "K173314", "K190626", "K250241", "K212442", "K222070", "K080847", "K212956", "K032761", "K173433", "K240099", "K183101", "K033486", "K173736", "K243328", "K234109", "K212212", "K254173", "K101833", "K974355", "K181767", "K193326", "K201156", "K052884", "K041605", "K172574", "K251602", "K221335", "K220627", "K233230", "K161976", "K024200", "K133535", "K040675", "K123508", "K070123", "K921219", "K936180", "K993037", "K230871", "K023178", "K163715", "K170832", "K240020", "K133819", "K143225", "K223410", "K033737", "K253670", "K220342", "K132094", "K243646", "K011292", "K153244", "K221922", "K992660", "K243446", "K240199", "K011311", "K230949", "K200218", "K171565", "K171755", "K230787", "K010435", "K243303", "K170752", "K202431", "K203551", "K254205", "K082243", "K141979", "K162859", "K221344", "K170909", "K181966", "K181407", "K172646", "K122234", "K142708", "K252735", "K181804", "K183109", "K043076", "K231692", "K190497", "K142736", "K091658", "K132305", "K200663" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2", "registration_number": [ "3005172103", 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