{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218977", "product_res_number": "Z-1692-2026", "event_date_initiated": "2026-03-05", "event_date_posted": "2026-03-27", "recall_status": "Open, Classified", "res_event_number": "98520", "product_code": "LLZ", "k_numbers": [ "K151774" ], "product_description": "Vue Motion V12. Product Number: 1017979.", "code_info": "Product Number: 1017979, Software Version: v12.2.0 - v12.2.8.500. 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114785236, 86072991, 89121552, 86326155, 86241451, 86241436, 89579112, 86093650, 86093336, 87129101, 117633052, 94491370, 88467413, 87976723, 89552593, 89552537, 86365080, 86365075, 95010778", "firm_fei_number": "3002807880", "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "address_1": "Veenpluis 4-6 4-6 veenpluis", "city": "Best", "country": "Netherlands", "additional_info_contact": "Informatics Customer Support\n877-3282808 Ext. 4", "reason_for_recall": "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.", "root_cause_description": "Software design", "action": "Philips Medical notified consignees on about 03/02/2026 via URGENT Medical Device Correction letter. Consignees were instructed to first identify, and how to identify, if the affected products are on hand. If so, they were further instructed that if they do NOT have thumbnail enabled, they will NOT experience this issue described, but if they HAVE thumbnail enabled, when reviewing multi frame studies, always review the frame number displayed on the screen as the correct frame number is visible on the screen. Consignees were told that they may continue to use your system(s) in accordance with the intended use and by provided the recommendation in the letter, to circulate the letter to all users of this device so that they are aware of the potential issue retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Consignees were also requested to complete and return the provided response form. \n\nA Philips representative will contact each consignee to schedule a time to install a software solution on the affected system(s) to resolve the issue (reference C&R 2025-EI-RI-003).", "product_quantity": "3,552 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Algeria, Andorra, Angola, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Guernsey, Holy See (Vatican City State), Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Zambia.", "openfda": { "k_number": [ "K170167", "K980060", "K051315", "K231353", "K223152", "K241765", "K991738", "K945389", "K053347", "K211966", "K100292", "K062650", "K211039", "K013922", "K132824", "K992112", "K925963", "K041990", "K222975", "K050862", "K080325", "K211429", "K992925", "K051392", "K061696", "K192279", "K183248", "K021966", "K050744", "K090833", "K120135", "K190162", "K232456", "K113620", "K180563", "K042525", "K063199", "K240294", "K170702", "K111024", "K041162", "K192165", "K172224", "K213128", "K210653", "K182230", "K170580", "K142196", "K040486", "K854810", "K090050", "K161601", "K160584", "K021191", "K151859", "K253495", "K081055", "K120115", "K172490", "K181264", "K945582", "K251109", "K003746", "K243447", "K042008", "K020483", "K190087", "K033361", "K162112", "K190074", "K182750", "K203743", "K131392", "K100236", 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