{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199808", "product_res_number": "Z-1647-2023", "event_date_initiated": "2023-03-21", "event_date_posted": "2024-09-30", "recall_status": "Open, Classified", "res_event_number": "92165", "product_code": "OWB", "k_numbers": [ "K181830" ], "product_description": "Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.\nModels/Model Number: \n(1) Azurion 3M12:\t722063, 722221;\n(2) Azurion 3M15:\t722064, 722222;\n(3) Azurion SM12:\t722227;\n(4) Azurion SM20:\t722228;\n(5) Azurion 7B12/12: 722067, 722225;\n(6) Azurion 7820/15:\t722068, 722226;\n(7) Azurion 7M12:\t722078, 722223;\n(8) Azurion 7M20\t:\t722079, 722224", "code_info": "UDI-DI:\nSystem product name\tModel number\tUDI\n(1)Azurion 3M12:\n722063 \t(01)00884838085275(21)\n 722221\t(01)00884838099203(21);\n(2) Azurion 3M15:\n722064 (01)00884838085282(21)\n722222\t(01)00884838099210(21);\n(3) Azurion SM12:\t\n722227\t(01)00884838099227(21);\n(4) Azurion SM20:\t\n722228\t(01)00884838099234(21);\n(5) Azurion 7B12/12:\n722067\t(01)00884838085350(21)\n722225\t(01)00884838099265(21);\n(6) Azurion 7820/15:\t\n722068\t(01)00884838085367(21)\n722226\t(01)00884838099272(21);\n(7) Azurion 7M12:\t\n722078\t(01)00884838085251(21)\n722223\t(01)00884838099241(21);\n(8) Azurion 7M20:\n722079\t(01)00884838085268(21)\n722224\t(01)00884838099258(21),\n\n\n\n\nSoftware: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6", "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": "Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available\nthere will be a sudden interruption of the procedure", "root_cause_description": "Under Investigation by firm", "action": "Philips issued Urgent Medical Device Letter to US consignees via e-mail on March 21, 2023 and certified email on March 29, 2023. Letters outside of the U.S.A. will be distributed through the local Philips Organizations. Letter states reason for recall, health risk and action to take:\nKeep this Medical Device Correction with the documentation of the system until Philips corrects your system.\nCirculate this notice to all users of the system so that they are aware of the issue. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Medical Device Correction. US: Please return this signed form via email to: IGT_Recalls@philips.com or alternatively via regular mail to Philips at 222 Jacobs Street, Cambridge, MA 02141 for the attention of Mr. Roland Telson / 3rd Floor\n\n\nPhilips is working on a software release that will correct this issue (reference FCO72200528). In the interim, until this software is available and installed in your affected system(s), Philips will be removing the Log Trace Files from the affected systems to free up disk capacity (reference FCO72200529).\nPhilips will be prioritizing these activities based on the time the affected software release has been installed in the Philips Azurion system. You will be contacted by your local Philips representative to schedule these activities.\nIf you need any further information or support concerning this issue, contact your local Philips representative.", "product_quantity": "USA: \t1063 R.O.W. \t 2136", "distribution_pattern": "Nationwide \nForeign:\nAlgeria\nArgentina\nArmenia\nAustralia\nAustria\nBahrain\nBangladesh\nBelarus\nBelgium\nBolivia\nBrazil\nBulgaria\nCambodia\nChile\nChina\nColombia\nCosta Rica\nC¿te D'Ivoire\nCroatia\nCyprus\nCzech Republic\nDenmark\nDominican Rep\nEcuador\nEgypt\nEstonia\nFinland\nFrance\nFrench Polynesia\nGermany\nGreece\nHong Kong\nHungary\nIndia\nIndonesia\nIran\nIraq\nIreland\nIsrael\nItaly\nJapan\nJordan\nKazakhstan\nKenya\nKorea, Republic of\nKosovo\nKuwait\nLatvia\nLebanon\nLithuania\nMacao\nMacedonia\nMalaysia\nMexico\nMorocco\nMyanmar\nNepal\nNetherlands\nNew Zealand\nNicaragua\nNigeria\nNorway\nOman\nPakistan\nPalestine\nPalestine, State of\nPanama\nPeru\nPhilippines\nPoland\nPortugal\nPuerto Rico\nQatar\nRomania\nRussian Federation\nSaudi Arabia\nSenegal\nSerbia\nSingapore\nSlovakia\nSlovenia\nSouth Africa\nSouth Korea\nSpain\nSri Lanka\nSweden\nSwitzerland\nTaiwan\nThailand\nTunisia\nTurkey\nTurkmenistan\nUkraine\nUnited Kingdom\nUtd.Arab.Emir.\nUzbekistan\nVietnam\nYemen", "openfda": { "k_number": [ "K250010", "K202547", "K222070", "K181550", "K160455", "K120073", "K993037", "K203281", "K203535", "K021049", "K233107", "K160147", "K243884", "K082243", "K052884", "K113027", "K103416", "K193230", "K212442", "K172574", "K153232", "K173631", "K203551", "K190626", "K052202", "K113403", "K221922", "K162614", "K252229", "K210307", "K212159", "K251523", "K992660", "K203504", "K080847", "K253584", "K151000", "K252735", "K230787", "K250241", "K230950", "K970063", "K041780", "K921219", "K170130", "K093066", "K153147", "K261413", "K181415", "K190497", "K181830", "K230185", "K173433", "K173639", "K163140", "K220342", "K234067", "K030544", "K142273", "K102005", "K163715", "K243303", 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"3011491794", "3021060474", "3012911444", "3011240766", "3014343100", "3005430103", "3006972752", "3023003446", "3014279513", "3027373189", "3021027284", "1037955", "3021559833", "3010462278", "3005843418", "3038614464", "3003935342", "3018094310", "3010703925", "3008632256", "3011950073", "1047843", "3011713200", "3018596740", "3004198450", "3001722928", "3030691709" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }