Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026)...
FDA Device Recall #Z-2259-2026 - Class II, April 30, 2026
Recall Summary
| Recall Number | Z-2259-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 30, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best |
| Product Type | Devices |
Product Description
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);
Reason for Recall
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.
Lot / Code Information
1. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 445, 1555, 1114, 1529, 472, 1349, 1594, 1311, 1472, 1187, 1700, 1031, 912, 913, 940, 285, 1637, 5, 797, 639, 452, 1585, 535, 1338, 1641, 1916, 614, 605, 492, 1612, 505, 239, 1216, 1169, 1118, 115, 519, 356, 715, 423, 1399, 789, 1509, 1016, 875, 1923, 313, 314, 1919, 1458, 369, 1176, 1230, 1925, 339, 1325, 1633, 596, 1784, 464, 796, 1928, 1025, 292, 1669, 1697, 708, 1, 1760, 1452, 346, 961, 1172, 354, 416, 363, 582, 161, 569, 922; 2. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794, (01)00884838059030(21)939, (01)00884838059030(21)921, (01)00884838059030(21)286, (01)00884838059030(21)1440, (01)00884838059030(21)1144, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)107, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)656, (01)00884838059030(21)1261, (01)00884838059030(21)1170, (01)00884838059030(21)585, (01)00884838059030(21)1128, (01)00884838059030(21)882, (01)00884838059030(21)1230, (01)00884838059030(21)280, (01)00884838059030(21)488, (01)00884838059030(21)787, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)190, (01)00884838059030(21)1181, (01)00884838059030(21)694, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)1149, 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(01)00884838059030(21)687, (01)00884838059030(21)1304, (01)00884838059030(21)502, (01)00884838059030(21)1124, (01)00884838059030(21)174, (01)00884838059030(21)537, (01)00884838059030(21)1199, (01)00884838059030(21)1339, (01)00884838059030(21)1001, (01)00884838059030(21)1351, (01)00884838059030(21)1307, (01)00884838059030(21)134, (01)00884838059030(21)1137, (01)00884838059030(21)483, (01)00884838059030(21)1068, (01)00884838059030(21)760, (01)00884838059030(21)1008, (01)00884838059030(21)1213, (01)00884838059030(21)1092, (01)00884838059030(21)1151, (01)00884838059030(21)1083, (01)00884838059030(21)1268, (01)00884838059030(21)955, (01)00884838059030(21)711, (01)00884838059030(21)1145, (01)00884838059030(21)514, (01)00884838059030(21)1273, (01)00884838059030(21)66, (01)00884838059030(21)1157, (01)00884838059030(21)1119, (01)00884838059030(21)702, (01)00884838059030(21)860, (01)00884838059030(21)685, (01)00884838059030(21)686, (01)00884838059030(21)942, (01)00884838059030(21)357, 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(01)00884838059030(21)1097, (01)00884838059030(21)904, (01)00884838059030(21)199, (01)00884838059030(21)328, (01)00884838059030(21)182, (01)00884838059030(21)294, (01)00884838059030(21)103, (01)00884838059030(21)77, (01)00884838059030(21)122, (01)00884838059030(21)810, (01)00884838059030(21)184, (01)00884838059030(21)474, (01)00884838059030(21)471, (01)00884838059030(21)962, (01)00884838059030(21)138, (01)00884838059030(21)1182, (01)00884838059030(21)1090, (01)00884838059030(21)549, (01)00884838059030(21)1065, (01)00884838059030(21)1376, (01)00884838059030(21)1433, (01)00884838059030(21)1355, (01)00884838059030(21)689, (01)00884838059030(21)163, (01)00884838059030(21)631, (01)00884838059030(21)1303, (01)00884838059030(21)1155, (01)00884838059030(21)558, (01)00884838059030(21)804, (01)00884838059030(21)1044, (01)00884838059030(21)822, (01)00884838059030(21)852, (01)00884838059030(21)880, (01)00884838059030(21)476, (01)00884838059030(21)862, (01)00884838059030(21)1280, (01)00884838059030(21)1300, (01)00884838059030(21)858, (01)00884838059030(21)362, (01)00884838059030(21)1207, (01)00884838059030(21)1076, (01)00884838059030(21)874, (01)00884838059030(21)1218, (01)00884838059030(21)1313, (01)00884838059030(21)710, (01)00884838059030(21)934, (01)00884838059030(21)645, (01)00884838059030(21)855, (01)00884838059030(21)583, (01)00884838059030(21)94; 3. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)155, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)458, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)436, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054189(21)78, (01)00884838054189(21)432, (01)00884838054189(21)224, (01)00884838054189(21)1072, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)543, (01)00884838054189(21)1248, (01)00884838054189(21)561, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)344, (01)00884838054189(21)374, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)130, (01)00884838054189(21)370, (01)00884838054189(21)235, (01)00884838054189(21)190, (01)00884838054189(21)259, 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(01)00884838054189(21)192, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)381, (01)00884838054189(21)774, (01)00884838054189(21)368, (01)00884838054189(21)245, (01)00884838054189(21)485, (01)00884838054189(21)484, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)109, (01)00884838054189(21)110, (01)00884838054189(21)116, (01)00884838054189(21)604, (01)00884838054189(21)627, (01)00884838054189(21)319, (01)00884838054189(21)716, (01)00884838054189(21)396, (01)00884838054189(21)531, (01)00884838054189(21)156, (01)00884838054189(21)253, (01)00884838054189(21)965, (01)00884838054189(21)444, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)102, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)560, (01)00884838054189(21)297, (01)00884838054189(21)562, (01)00884838054189(21)11, (01)00884838054189(21)832, (01)00884838054189(21)335, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)215, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)614, (01)00884838054189(21)222, (01)00884838054189(21)205, (01)00884838054189(21)284, (01)00884838054189(21)115, (01)00884838054189(21)694, (01)00884838054189(21)74, (01)00884838054189(21)838, (01)00884838054189(21)244, (01)00884838054189(21)973, (01)00884838054189(21)985, (01)00884838054189(21)101, (01)00884838054189(21)855, (01)00884838054189(21)287, (01)00884838054189(21)378, (01)00884838054189(21)612, (01)00884838054189(21)725, (01)00884838054189(21)914, (01)00884838054189(21)805, (01)00884838054189(21)622, (01)00884838054189(21)234, (01)00884838054189(21)1293, (01)00884838054189(21)121, (01)00884838054189(21)512, (01)00884838054189(21)559, (01)00884838054189(21)1205, 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Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2932-2026 | Class II | Philips Azurion, Model Numbers: 722229, 722230... | Jul 16, 2026 |
| Z-2931-2026 | Class II | Philips Azurion Rystem, Model Numbers: 722063... | Jul 16, 2026 |
| Z-2928-2026 | Class II | Allura Xper FD. Model Numbers: 722026, 722027, ... | Jun 29, 2026 |
| Z-2891-2026 | Class II | Philips Allura under the following System Descr... | Jun 17, 2026 |
| Z-2893-2026 | Class II | Philips Allura, Cardio Vascular-Allura Centron.... | Jun 17, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.