{ "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": "191367", "product_res_number": "Z-0724-2022", "event_date_initiated": "2021-11-24", "event_date_created": "2022-03-04", "recall_status": "Open, Classified", "res_event_number": "89375", "product_code": "OWB", "k_numbers": [ "K141979", "K161563" ], "product_description": "Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray:\nModel Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039.\n\nAllura Xper F010 {C+F). 722003\nAllura Xper F010/10 722005\nAllura Xper F020 722006\nAllura Xper F020/10 and F020/20 722008\nAllura Xper F010 722010\nAltura Xper F010/10 722011\nAllura Xper F020 722012\nAllura Xper FD20 biplane 722013\nAllura Xper FDlO OR Table 722014\nAllura Xper FD20 OR Table 722015\nAllura Xper FDl0/10 OR Table 722019\nAllura Xper FD20 Biplane OR Table 722020\nAllura Xper FD10 OR Table 722022\nAllura Xper FD20 OR Table 722023\nAllura Xper FD10/10 OR Table 722024\nAltura Xper FD20 Biplane OR Table 722025\nAllura Xper FD10 722026\nAllura Xper FD10/10 722027\nAltura Xper FD20/10 biplane 722029\nAllura Xper FD10 OR Table 722033\nAllura Xper FD10/10 OR Table 722034\nAllura Xper FD20/10 OR Table 722036\nAllure Xper F020/20 722038\nAltura Xper FD20/20 biplane OR Table 722039", "code_info": "Allura Xper FD10 722003/722026  (US) S/N:  24 40 71 162 191 266 283 294 319 347 406 485 825 959 965 967 985 990 1246 1353 1444 1944 1949 UDI: (01)00884838054189(21)825 (01)00884838054189(21)967 (01)00884838054189(21)1246 (01)00884838054189(21)965 (01)00884838054189(21)959 (01)00884838054189(21)990 (01)00884838054189(21)985   Allura Xper FD10/10 722005 S/N: 144 US OUS: 37 52 74 79 80 108 279 417 459  Allura Xper FD20 722006 S/N: US 44 72 234 246 263 268 327 333 429 469 471 498 514 535 550 554 588 604 718 754 766 861 1174 1274 1355 1400 1783 1831 1844 1878 1886 1931 2018 UDI: (01)00884838054202(21)893  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554   Allura Xper FD20 Biplane 722008 S/N: 33, 82, 374 (US) OUS: 39 86 224 249 336 384 388 532   Allura Xper FD10 722010 S/N:OUS 163 340 1422 1429 1434  Allura Xper FD20 722012 S/N: OUS 395 463 927 1013 1518 2652 2854 2918  Allura Xper FD20 OR Table 722015 S/N: 30 (OUS)  Allura Xper FD10 722026 S/N OUS: 315 701 748 884 888 943 948 960 971 975 978 984 989 995  Allura Xper FD10/10 722027 S/N: OUS 268 278  Allura Xper FD20/10 722029 S/N:OUS 9  Allura Xper FD10 722026 S/N : US 825 959 965 967 985 990 1246  OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554  Allura Xper FD10/10\t266 722027 S/N: 266  Allura Xper FD20 722028 S/N: 893 UDI: (01)00884838054202(21)893  Allura Xper FD20/10 722029 S/N: 91, 94 US UDI: (01)00884838054219(21)94 OUS:  S/N:6", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "reason_for_recall": "Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.", "root_cause_description": "Process control", "action": "Philips Issued Medical Device Correction letter dated 11/24/21 to U.S.A, Customers via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and action to take:\nPhilips will inspect the affected systems for leaks and repair as required. In addition, Philips will install an extended drip tray to prevent damage from any future leaks. This service will be provided free of charge for affected systems.\nA Philips service representative will contact customers with affected devices to arrange for the service.\nIf you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 (reference FCC 72200484).", "product_quantity": "USA: 63 systems\tR.O.W.: 127 systems", "distribution_pattern": "US Nationwide\nForeign:\nArgentina\nAustria\nBangladesh\nBrazil\nChile\nChina\nDenmark\nDominican Republic\nFrance\nGermany\nGreece\nIndia\nIndonesia\nIran\nIsrael\nItaly\nJapan\nKorea, Republic of\nMalaysia\nMexico\nNetherlands\nPhilippines\nRussian Federation\nSaudi Arabia\nSouth Africa\nSpain\nSri Lanka\nSwitzerland\nTaiwan\nThailand\nTurkey\nUnited Kingdom\nVirgin Islands (U.S.)", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", 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