{ "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": 1 } }, "results": [ { "cfres_id": "217624", "product_res_number": "Z-1113-2026", "event_date_initiated": "2025-12-12", "event_date_posted": "2026-01-16", "recall_status": "Open, Classified", "res_event_number": "98108", "product_code": "OWB", "k_numbers": [ "K200917" ], "product_description": "Philips Azurion system; Software Version Number: R3.1;", "code_info": "Software Version Number: R3.1;\n\n(1) Model Number: 722221;\nSystem Product Name: Azurion 3 M12;\nUDI-DI: 00884838099203;\nSerial Numbers: \n\n(2) Model Number: 722222;\nSystem Product Name: Azurion 3 M15;\nUDI-DI: 00884838099210;\nSerial Numbers:\n\n(3) Model Number: 722223;\nSystem Product Name: Azurion 7 M12;\nUDI-DI: 00884838099241;\nSerial Numbers:\n\n(4) Model Number: 722224;\nSystem Product Name: Azurion 7 M20;\nUDI-DI: 00884838099258;\nSerial Numbers:\n\n(5) Model Number: 722225;\nSystem Product Name: Azurion 7 B12;\nUDI-DI: 00884838099265;\nSerial Numbers:\n\n(6) Model Number: 722226;\nSystem Product Name: Azurion 7 B20;\nUDI-DI: 00884838099272;\nSerial Numbers:\n\n(7) Model Number: 722227;\nSystem Product Name: Azurion 5 M12;\nUDI-DI: 00884838099227;\nSerial Numbers:\n\n(8) Model Number: 722228;\nSystem Product Name: Azurion 5 M20;\nUDI-DI: 00884838099234;\nSerial Numbers:\n\n(9) Model Number: 722229;\nSystem Product Name: Azurion 3 M12;\nUDI-DI: 00884838116726;\nSerial Numbers: 5, 9, 32, 40, 35, 31, 33;\n\n(10) Model Number: 722230;\nSystem Product Name: Azurion 3 M15;\nUDI-DI: 00884838116733;\nSerial Numbers: 25, 54, 50, 52, 55, 30, 63, 60, 67;\n\n(11) Model Number: 722231;\nSystem Product Name: Azurion 5 M12;\nUDI-DI: 00884838116740;\nSerial Numbers: 62, 7, 8, 14, 17, 63, 6, 66, 59, 69, 56, 67, 48, 68, 80, 93, 87, 94, 81, 92, 18;\n\n(12) Model Number: 722232;\nSystem Product Name: Azurion 5 M20;\nUDI-DI: 00884838116757;\nSerial Numbers: 97, 39, 31, 100, 104, 93, 115, 113, 118, 119, 89, 54, 67, 7, 128, 86, 110, 132, 130, 131, 123, 137, 139, 117, 260;\n\n(13) Model Number: 722233;\nSystem Product Name: Azurion 7 M12;\nUDI-DI: 00884838116764;\nSerial Numbers: 239, 100, 233, 240, 176, 227, 223, 130, 161, 194, 243, 56, 193, 280, 75, 253, 156, 288, 72, 281, 304, 300, 105, 295, 312, 310, 285, 292, 290, 298, 297;\n\n(14) Model Number: 722234;\nSystem Product Name: Azurion 7 M20;\nUDI-DI: 00884838116771;\nSerial Numbers: 731, 727, 261, 473, 683, 722, 562, 750, 745, 766, 265, 701, 400, 310, 421, 314, 182, 579, 96, 763, 272, 612, 15, 844, 105, 702, 751, 384, 851, 869, 743, 337, 651, 455, 706, 312, 563, 709, 764, 871, 846, 278, 713, 802, 868, 277, 742, 184, 819, 759, 910, 928, 415, 414, 945, 961, 355, 933, 692, 920, 569, 939, 909, 553, 837, 856, 571, 756, 941, 570, 761, 981, 353, 888, 964, 820, 746, 736, 876, 599, 1017, 908, 487, 983, 495;\n\n(15) Model Number: 722235;\nSystem Product Name: Azurion 7 B12;\nUDI-DI: 00884838116788;\nSerial Numbers: 96, 79, 111, 100, 101, 38, 27, 92, 78, 118, 48, 131, 135, 22, 125, 103, 138, 139, 137;\n\n(16) Model Number: 722236;\nSystem Product Name: Azurion 7 B20;\nUDI-DI: 00884838116801;\nSerial Numbers: 241, 297, 198, 215, 305, 274, 299, 78, 279, 287, 318, 353, 324, 331, 293, 245, 314, 310, 317, 312, 77, 358, 206, 383, 380, 370, 377, 385, 405, 379, 328;", "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 two (2) software issues affecting device systems that may result in loss of\nimaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content\nand/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.", "root_cause_description": "Software design", "action": "On December 12, 2025, Philips sent URGENT Medical Device Correction letters to customers.\nActions to be taken:\n-\tCirculate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issues. \n\"\tIn case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative.\n\"\tKeep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed.\n\"\tComplete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issues and required actions to be taken. \n\"\tIf you experience an issue described in this letter, please report it to your local Philips representative.\n\nYour local Philips representative will contact you to schedule visits to install the software updates once available. \n\n***Update May 8, 2026***\n\nPreviously, Philips planned to resolve issue 1 with software update 3.1.5 and issue 2 with software update 3.1.15. \n\nPhilips has now updated their plan thusly:\n\nBoth issues 1 and 2 will be included with software release 3.1.15. Anticipated release date of software version 3.1.15 has been moved to Q3 2026.", "product_quantity": "228 units (all OUS)", "distribution_pattern": "International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;", "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", 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], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2", "registration_number": [ "3005172103", "3016438694", "3004785967", "1052701", "9614698", "3010685285", "3031503890", "3033527282", "9681146", "3033525986", "3047907228", "3012911444", "3030412764", "3008632256", "3009196578", "3009001657", "3011713200", "1056553", "1047843", "3008253300", "3038614464", "3008284470", "3036666444", "1000181430", "3003202425", "3043048939", "3011347852", "3019878714", "3030691709", "3004198450", "3021559833", "3004026651", "3010398867", "3018596740", "2027467", "3001722928", "3006128100", "3013944123", "3013184485", "3021060474", "3017375271", "3011240766", "3011015597", "3014279513", "3026391023", "3027373189", "3012761544", "2031966", "3030089787", "3014343100", "3021561977", "2243057", "3012624817", "3010162973", "3005810333", "3018077344", "3015437189", "3025394757", "3005706667", 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