{ "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": "205367", "product_res_number": "Z-0835-2024", "event_date_initiated": "2023-12-12", "event_date_posted": "2024-01-26", "recall_status": "Open, Classified", "res_event_number": "93755", "product_code": "OWB", "k_numbers": [ "K200917" ], "product_description": "Philips Azurion system, Interventional fluoroscopic x-ray system. \n\nSystem Product Name - Model Numbers\nAzurion 3M12 -722063, 722221;\nAzurion 3M15 - 722064, 722222;\nAzurion 5M12 - 722227;\nAzurion 5M20 - 722228;\nAzurion 7B12/12 - 722067, 722225;\nAzurion 7B20/15 - 722068, 722226;\nAzurion 7M12 - 722078, 722223;\nAzurion 7M20 - 722079, 722224;\nAzurion 3 M15 (China) - 722280;", "code_info": "System Product Name - UDI-DI\nAzurion 3M12 - 00884838085275, 00884838099203, 00884838101890;\nAzurion 3M15 - 00884838085282, 00884838099210;\nAzurion 5M12 - 00884838099227;\nAzurion 5M20 - 00884838099234;\nAzurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265;\nAzurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883;\nAzurion 7M12 - 00884838085251, 00884838099241, 00884838101890;\nAzurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890;\nAzurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276;\n\n\nSoftware Version Numbers R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2", "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": "System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.", "root_cause_description": "Under Investigation by firm", "action": "On December 12, 2023, the firm notified customers via certified mailing of URGENT Medical Device Correction letters.\n\nCustomers may identify affected products by the system product name and model number, which can be found on the System Identification Label located on the system stand. The software version of the Philips Azurion system can be identified during start-up.\n\nCustomers were advised to keep the number of studies in the patient database as low as possible, but at least below 500. Customers should keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system. Ensure that all users of the system are notified of the issue.\n\nPhilips is working on a software release that will correct this issue. Philips representatives will contact affected customers to schedule the correction. Please contact your local Philips representative for further information or support concerning this issue.", "product_quantity": "1,799 US; 5,747 OUS", "distribution_pattern": "Worldwide - US Nationwide distribution.", "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", 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