Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper F...
FDA Device Recall #Z-2228-2026 - Class II, April 28, 2026
Recall Summary
| Recall Number | Z-2228-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 28, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best |
| Product Type | Devices |
| Quantity | 3314 units (816 US, 2498 OUS) |
Product Description
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), 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), Cardio Vascular-Allura (722400);
Reason for Recall
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Distribution Pattern
Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;
Lot / Code Information
Code Information: Allura: 1. Allura Xper FD10C; Model: 722001; UDI-DI: N/A; Serial Numbers: 170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F; Model: 722002; UDI-DI: N/A; Serial Numbers: 0, 81, 47; 3. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 208, 392, 109, 45, 1953, 1471, 1551, 485, 152, 928, 501, 90, 1435, 81, 939, 160, 472, 1349, 439, 1958, 1525, 72, 1187, 912, 368, 328A, 37, 1286, 1223, 487, 1061, 833, 688, 317, 157, 639, 375, 420, 225, 1338, 614, 214, 230, 736, 64, 1090, 1094, 1932, 1531, 421, 984, 373, 313, 918, 602, 374, 750, 1934, 1751, 1661, 961, 791, 454, 868, 416, 1329, 241; 4. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)921, (01)00884838059030(21)1440, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1428, (01)00884838059030(21)1396, (01)00884838059030(21)298, (01)00884838059030(21)1432, (01)00884838059030(21)1425, (01)00884838059030(21)1398, (01)00884838059030(21)1397, (01)00884838059030(21)1391, (01)00884838059030(21)1395, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)946, (01)00884838059030(21)1424, (01)00884838059030(21)1244, (01)00884838059030(21)1122, (01)00884838059030(21)1198, (01)00884838059030(21)1421, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)697, (01)00884838059030(21)1192, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)1148, (01)00884838059030(21)1439, (01)00884838059030(21)1431, (01)00884838059030(21)1404, (01)00884838059030(21)1140, (01)00884838059030(21)1429, (01)00884838059030(21)1430, (01)00884838059030(21)1403, (01)00884838059030(21)1393, (01)00884838059030(21)1402, (01)00884838059030(21)406, (01)00884838059030(21)71, (01)00884838059030(21)1434, (01)00884838059030(21)1392, (01)00884838059030(21)1379, (01)00884838059030(21)1401, (01)00884838059030(21)1197, (01)00884838059030(21)1435, (01)00884838059030(21)1346, (01)00884838059030(21)232, (01)00884838059030(21)231, (01)00884838059030(21)248, (01)00884838059030(21)1137, (01)00884838059030(21)1446, (01)00884838059030(21)1422, (01)00884838059030(21)1433, (01)00884838059030(21)1131, (01)00884838059030(21)1218; 5. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)1052, (01)00884838054189(21)1051, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)1072, (01)00884838054189(21)796, (01)00884838054189(21)1248, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)969, (01)00884838054189(21)1246, (01)00884838054189(21)877, (01)00884838054189(21)843, (01)00884838054189(21)1231, (01)00884838054189(21)1038, (01)00884838054189(21)1287, (01)00884838054189(21)878, (01)00884838054189(21)558, (01)00884838054189(21)633, (01)00884838054189(21)1050, (01)00884838054189(21)1000, (01)00884838054189(21)909, (01)00884838054189(21)841, (01)00884838054189(21)713, (01)00884838054189(21)731, (01)00884838054189(21)646, (01)00884838054189(21)728, (01)00884838054189(21)765, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)774, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)627, (01)00884838054189(21)604, (01)00884838054189(21)716, (01)00884838054189(21)1182, (01)00884838054189(21)965, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)694, (01)00884838054189(21)838, (01)00884838054189(21)973, (01)00884838054189(21)985, (01)00884838054189(21)855, (01)00884838054189(21)612, (01)00884838054189(21)725, (01)00884838054189(21)805, (01)00884838054189(21)622, (01)00884838054189(21)1293, (01)00884838054189(21)1205, (01)00884838054189(21)617, (01)00884838054189(21)1101, (01)00884838054189(21)738, (01)00884838054189(21)957, (01)00884838054189(21)1340, (01)00884838054189(21)653, (01)00884838054189(21)663, (01)00884838054189(21)688, (01)00884838054189(21)704, (01)00884838054189(21)931, (01)00884838054189(21)967, (01)00884838054189(21)826, (01)00884838054189(21)998, (01)00884838054189(21)807, (01)00884838054189(21)986, (01)00884838054189(21)962, (01)00884838054189(21)961, (01)00884838054189(21)1049, (01)00884838054189(21)707, (01)00884838054189(21)866, (01)00884838054189(21)759, (01)00884838054189(21)1115, (01)00884838054189(21)830, (01)00884838054189(21)638, (01)00884838054189(21)1316, (01)00884838054189(21)748, (01)00884838054189(21)1278, (01)00884838054189(21)1104, (01)00884838054189(21)1368, (01)00884838054189(21)977, (01)00884838054189(21)1001, (01)00884838054189(21)806, (01)00884838054189(21)769, (01)00884838054189(21)771, (01)00884838054189(21)881, (01)00884838054189(21)581, (01)00884838054189(21)1307, (01)00884838054189(21)1128, (01)00884838054189(21)1127, (01)00884838054189(21)1092, (01)00884838054189(21)276, (01)00884838054189(21)722, (01)00884838054189(21)1188, (01)00884838054189(21)1326, (01)00884838054189(21)809, (01)00884838054189(21)729, (01)00884838054189(21)894, (01)00884838054189(21)1018, (01)00884838054189(21)978, (01)00884838054189(21)1201, (01)00884838054189(21)1202, (01)00884838054189(21)1204, (01)00884838054189(21)564, (01)00884838054189(21)1349, (01)00884838054189(21)1227, (01)00884838054189(21)1220, (01)00884838054189(21)1221, (01)00884838054189(21)650, (01)00884838054189(21)794, (01)00884838054189(21)681, (01)00884838054189(21)545, (01)00884838054189(21)1228, (01)00884838054189(21)1321, (01)00884838054189(21)1071, (01)00884838054189(21)1341, (01)00884838054189(21)897, (01)00884838054189(21)619, (01)00884838054189(21)1107, (01)00884838054189(21)1033, (01)00884838054189(21)804, (01)00884838054189(21)677, (01)00884838054189(21)678, (01)00884838054189(21)1271, (01)00884838054189(21)587, (01)00884838054189(21)1347, (01)00884838054189(21)1037, (01)00884838054189(21)709, (01)00884838054189(21)1203, (01)00884838054189(21)930, (01)00884838054189(21)609, (01)00884838054189(21)569, (01)00884838054189(21)979, (01)00884838054189(21)1313, (01)00884838054189(21)1093, (01)00884838054189(21)1054, (01)00884838054189(21)960, (01)00884838054189(21)928, (01)00884838054189(21)924, (01)00884838054189(21)1233, (01)00884838054189(21)721, (01)00884838054189(21)720, (01)00884838054189(21)1117, (01)00884838054189(21)1146, (01)00884838054189(21)858, (01)00884838054189(21)744, (01)00884838054189(21)745, (01)00884838054189(21)1272, (01)00884838054189(21)1249, (01)00884838054189(21)1091, (01)00884838054189(21)1064, (01)00884838054189(21)863, (01)00884838054189(21)697, (01)00884838054189(21)692, (01)00884838054189(21)756, (01)00884838054189(21)628, (01)00884838054189(21)749, (01)00884838054189(21)611, (01)00884838054189(21)1121, (01)00884838054189(21)1265, (01)00884838054189(21)1264, (01)00884838054189(21)1108, (01)00884838054189(21)662, (01)00884838054189(21)754, (01)00884838054189(21)1031, (01)00884838054189(21)997, (01)00884838054189(21)1356, (01)00884838054189(21)1305, (01)00884838054189(21)1355, (01)00884838054189(21)1362, (01)00884838054189(21)1329, (01)00884838054189(21)1360, (01)00884838054189(21)1364, (01)00884838054189(21)1363, (01)00884838054189(21)1366, (01)00884838054189(21)1199, (01)00884838054189(21)1123, (01)00884838054189(21)1113, (01)00884838054189(21)1026, (01)00884838054189(21)1029, (01)00884838054189(21)884, (01)00884838054189(21)902, (01)00884838054189(21)751, (01)00884838054189(21)753, (01)00884838054189(21)687, (01)00884838054189(21)1301, (01)00884838054189(21)944, (01)00884838054189(21)1196, (01)00884838054189(21)1147, (01)00884838054189(21)938, (01)00884838054189(21)686, (01)00884838054189(21)1019, (01)00884838054189(21)1103, (01)00884838054189(21)679, (01)00884838054189(21)1276, (01)00884838054189(21)927, (01)00884838054189(21)1245, (01)00884838054189(21)575, (01)00884838054189(21)1173, (01)00884838054189(21)589, (01)00884838054189(21)763, (01)00884838054189(21)594, (01)00884838054189(21)723, (01)00884838054189(21)1195, (01)00884838054189(21)656, (01)00884838054189(21)657, (01)00884838054189(21)658, (01)00884838054189(21)857, (01)00884838054189(21)803, (01)00884838054189(21)854, (01)00884838054189(21)779, (01)00884838054189(21)632, (01)00884838054189(21)1165, (01)00884838054189(21)1218, (01)00884838054189(21)1327, (01)00884838054189(21)730, (01)00884838054189(21)1286, (01)00884838054189(21)941, (01)00884838054189(21)915, (01)00884838054189(21)1229, (01)00884838054189(21)643, (01)00884838054189(21)726, (01)00884838054189(21)846, (01)00884838054189(21)637, (01)00884838054189(21)792, (01)00884838054189(21)810, (01)00884838054189(21)995, (01)00884838054189(21)1277, (01)00884838054189(21)1005, (01)00884838054189(21)1106, (01)00884838054189(21)620, (01)00884838054189(21)747, (01)00884838054189(21)783, (01)00884838054189(21)1275, (01)00884838054189(21)1118, (01)00884838054189(21)689, (01)00884838054189(21)1186, (01)00884838054189(21)1250, (01)00884838054189(21)1034, (01)00884838054189(21)631, (01)00884838054189(21)1230, (01)00884838054189(21)1372, (01)00884838054189(21)1046, (01)00884838054189(21)1047, (01)00884838054189(21)1306, (01)00884838054189(21)975, (01)00884838054189(21)626, (01)00884838054189(21)1255, (01)00884838054189(21)1184, (01)00884838054189(21)768, (01)00884838054189(21)917, (01)00884838054189(21)695, (01)00884838054189(21)780, (01)00884838054189(21)1179, (01)00884838054189(21)1208, (01)00884838054189(21)913, (01)00884838054189(21)1152, (01)00884838054189(21)1170, (01)00884838054189(21)840, (01)00884838054189(21)764, (01)00884838054189(21)936, (01)00884838054189(21)1053, (01)00884838054189(21)635, (01)00884838054189(21)606, (01)00884838054189(21)1371, (01)00884838054189(21)895, (01)00884838054189(21)630, (01)00884838054189(21)899, (01)00884838054189(21)734, (01)00884838054189(21)1308, (01)00884838054189(21)719, (01)00884838054189(21)593, (01)00884838054189(21)851, (01)00884838054189(21)1303, (01)00884838054189(21)727, (01)00884838054189(21)520, (01)00884838054189(21)1163, (01)00884838054189(21)903, (01)00884838054189(21)661, (01)00884838054189(21)1177, (01)00884838054189(21)1013, (01)00884838054189(21)1015, (01)00884838054189(21)1012, (01)00884838054189(21)1016, (01)00884838054189(21)871, (01)00884838054189(21)880, (01)00884838054189(21)1187, (01)00884838054189(21)1008, (01)00884838054189(21)940, (01)00884838054189(21)1191, (01)00884838054189(21)1216, (01)00884838054189(21)739, (01)00884838054189(21)624, (01)00884838054189(21)1185, (01)00884838054189(21)1353, (01)00884838054189(21)1296, (01)00884838054189(21)740, (01)00884838054189(21)1044, (01)00884838054189(21)1240, (01)00884838054189(21)625, (01)00884838054189(21)1190, (01)00884838054189(21)932, (01)00884838054189(21)1070, (01)00884838054189(21)1096, (01)00884838054189(21)943, (01)00884838054189(21)1243, (01)00884838054189(21)1097, (01)00884838054189(21)836, (01)00884838054189(21)1021, (01)00884838054189(21)1006, (01)00884838054189(21)1241, (01)00884838054189(21)1242, (01)00884838054189(21)761, (01)00884838054189(21)1359, (01)00884838054189(21)1194, (01)00884838054189(21)666, (01)00884838054189(21)1098, (01)00884838054189(21)649, (01)00884838054189(21)818, (01)00884838054189(21)958, (01)00884838054189(21)1048, (01)00884838054189(21)916, (01)00884838054189(21)703, (01)00884838054189(21)1289, (01)00884838054189(21)812, (01)00884838054189(21)1280, (01)00884838054189(21)1281, (01)00884838054189(21)951, (01)00884838054189(21)1171, (01)00884838054189(21)1175, (01)00884838054189(21)762, (01)00884838054189(21)1343, (01)00884838054189(21)610, (01)00884838054189(21)1145, (01)00884838054189(21)1065, (01)00884838054189(21)773, (01)00884838054189(21)1320, (01)00884838054189(21)912, (01)00884838054189(21)1138, (01)00884838054189(21)814, (01)00884838054189(21)1234, (01)00884838054189(21)691, (01)00884838054189(21)1174, (01)00884838054189(21)1136, (01)00884838054189(21)789, (01)00884838054189(21)672, (01)00884838054189(21)640, (01)00884838054189(21)641, (01)00884838054189(21)642, (01)00884838054189(21)1119, (01)00884838054189(21)873, (01)00884838054189(21)868, (01)00884838054189(21)816, (01)00884838054189(21)1086, (01)00884838054189(21)898, (01)00884838054189(21)551, (01)00884838054189(21)766, (01)00884838054189(21)1150, (01)00884838054189(21)574, (01)00884838054189(21)1155, (01)00884838054189(21)1213, (01)00884838054189(21)970, (01)00884838054189(21)1352, (01)00884838054189(21)1226, (01)00884838054189(21)988, (01)00884838054189(21)994, (01)00884838054189(21)1169, (01)00884838054189(21)752, (01)00884838054189(21)732, (01)00884838054189(21)659, (01)00884838054189(21)956, (01)00884838054189(21)1120, (01)00884838054189(21)1022, (01)00884838054189(21)901, (01)00884838054189(21)815, (01)00884838054189(21)1133, (01)00884838054189(21)1354, (01)00884838054189(21)735, (01)00884838054189(21)1267, (01)00884838054189(21)1318, (01)00884838054189(21)1261, (01)00884838054189(21)1035, (01)00884838054189(21)1010, (01)00884838054189(21)1315, (01)00884838054189(21)1314, (01)00884838054189(21)1116, (01)00884838054189(21)1217, (01)00884838054189(21)1282, (01)00884838054189(21)1009, (01)00884838054189(21)1302, (01)00884838054189(21)1076, (01)00884838054189(21)1346, (01)00884838054189(21)833, (01)00884838054189(21)1331, (01)00884838054189(21)1028, (01)00884838054189(21)1062, (01)00884838054189(21)1358, (01)00884838054189(21)1154, (01)00884838054189(21)989, (01)00884838054189(21)1336, (01)00884838054189(21)1319, (01)00884838054189(21)1310, (01)00884838054189(21)1309, (01)00884838054189(21)891, (01)00884838054189(21)1262, (01)00884838054189(21)1334, (01)00884838054189(21)1339, (01)00884838054189(21)1283, (01)00884838054189(21)1109, (01)00884838054189(21)1252, (01)00884838054189(21)1342, (01)00884838054189(21)708, (01)00884838054189(21)1335, (01)00884838054189(21)987, (01)00884838054189(21)1159, (01)00884838054189(21)1266, (01)00884838054189(21)1153, (01)00884838054189(21)1063, (01)00884838054189(21)1292, (01)00884838054189(21)981, (01)00884838054189(21)948, (01)00884838054189(21)859, (01)00884838054189(21)1007, (01)00884838054189(21)1328, (01)00884838054189(21)1332, (01)00884838054189(21)1351, (01)00884838054189(21)760, (01)00884838054189(21)1256, (01)00884838054189(21)984, (01)00884838054189(21)1161, (01)00884838054189(21)636, (01)00884838054189(21)1294, (01)00884838054189(21)1122, (01)00884838054189(21)939, (01)00884838054189(21)1274, (01)00884838054189(21)1176, (01)00884838054189(21)767, (01)00884838054189(21)1269, (01)00884838054189(21)1214, (01)00884838054189(21)1348, (01)00884838054189(21)1270, (01)00884838054189(21)1164, (01)00884838054189(21)1259, (01)00884838054189(21)1260, (01)00884838054189(21)1135, (01)00884838054189(21)1312, (01)00884838054189(21)1209, (01)00884838054189(21)992, (01)00884838054189(21)844, (01)00884838054189(21)1317, (01)00884838054189(21)621, (01)00884838054189(21)1219, (01)00884838054189(21)875, (01)00884838054189(21)937, (01)00884838054189(21)971, (01)00884838054189(21)714, (01)00884838054189(21)742, (01)00884838054189(21)1224, (01)00884838054189(21)1137, (01)00884838054189(21)651, (01)00884838054189(21)1168, (01)00884838054189(21)701, (01)00884838054189(21)777, (01)00884838054189(21)776, (01)00884838054189(21)1149, (01)00884838054189(21)1207, (01)00884838054189(21)1206, (01)00884838054189(21)1330, (01)00884838054189(21)919, (01)00884838054189(21)741, (01)00884838054189(21)1279, (01)00884838054189(21)1066, (01)00884838054189(21)922, (01)00884838054189(21)808, (01)00884838054189(21)1125, (01)00884838054189(21)338, (01)00884838054189(21)1156, (01)00884838054189(21)1222, (01)00884838054189(21)673, (01)00884838054189(21)835, (01)00884838054189(21)737, (01)00884838054189(21)811, (01)00884838054189(21)1144, (01)00884838054189(21)1143, (01)00884838054189(21)867, (01)00884838054189(21)869, (01)00884838054189(21)702, (01)00884838054189(21)918, (01)00884838054189(21)1140, (01)00884838054189(21)790, (01)00884838054189(21)660, (01)00884838054189(21)1370, (01)00884838054189(21)1045, (01)00884838054189(21)824, (01)00884838054189(21)712, (01)00884838054189(21)1027, (01)00884838054189(21)582, (01)00884838054189(21)1020, (01)00884838054189(21)684, (01)00884838054189(21)736, (01)00884838054189(21)652, (01)00884838054189(21)1225, (01)00884838054189(21)758, (01)00884838054189(21)926, (01)00884838054189(21)724, (01)00884838054189(21)950, (01)00884838054189(21)549, (01)00884838054189(21)819, (01)00884838054189(21)983, (01)00884838054189(21)921, (01)00884838054189(21)821, (01)00884838054189(21)1311, (01)00884838054189(21)1158, (01)00884838054189(21)1157, (01)00884838054189(21)772, (01)00884838054189(21)1023, (01)00884838054189(21)784, (01)00884838054189(21)1004, (01)00884838054189(21)886, (01)00884838054189(21)887, (01)00884838054189(21)1102, (01)00884838054189(21)1002, (01)00884838054189(21)308, (01)00884838054189(21)1058, (01)00884838054189(21)896, (01)00884838054189(21)710, (01)00884838054189(21)1151, (01)00884838054189(21)706, (01)00884838054189(21)443, (01)00884838054189(21)442, (01)00884838054189(21)547, (01)00884838054189(21)870, (01)00884838054189(21)1365, (01)00884838054189(21)889, (01)00884838054189(21)412, (01)00884838054189(21)862, (01)00884838054189(21)1369, (01)00884838054189(21)1090, (01)00884838054189(21)1273, (01)00884838054189(21)788, (01)00884838054189(21)1345, (01)00884838054189(21)1344, (01)00884838054189(21)827, (01)00884838054189(21)1030, (01)00884838054189(21)1178, (01)00884838054189(21)1131, (01)00884838054189(21)675, (01)00884838054189(21)1322, (01)00884838054189(21)623, (01)00884838054189(21)853, (01)00884838054189(21)1172, (01)00884838054189(21)892, (01)00884838054189(21)588, (01)00884838054189(21)1257, (01)00884838054189(21)743, (01)00884838054189(21)1162, (01)00884838054189(21)1323, (01)00884838054189(21)1325, (01)00884838054189(21)876, (01)00884838054189(21)655, (01)00884838054189(21)974, (01)00884838054189(21)793, (01)00884838054189(21)907, (01)00884838054189(21)1251, (01)00884838054189(21)669; 6. Allura Xper FD10/10; Model: 722005; UDI-DI: N/A: Serial Numbers: 51, 22, 259, 196, 530, 435, 233, 309, 89, 29, 399, 480, 6, 41, 71, 124, 458, 54, 55, 528, 80, 556, 74, 203, 60, 125, 426, 123, 64, 299; 7. Allura Xper FD10/10; Model: 722011; UDI: (01)00884838059047(21)49, (01)00884838059047(21)196, (01)00884838059047(21)157, (01)00884838059047(21)82, (01)00884838059047(21)83, (01)00884838059047(21)275, (01)00884838059047(21)101, (01)00884838059047(21)347, (01)00884838059047(21)198, (01)00884838059047(21)94, (01)00884838059047(21)176, (01)00884838059047(21)329, (01)00884838059047(21)337; 8. Allura Xper FD10/10; Model: 722027; UDI: (01)00884838054196(21)351, (01)00884838054196(21)332, (01)00884838054196(21)71, (01)00884838054196(21)240, (01)00884838054196(21)241, (01)00884838054196(21)298, (01)00884838054196(21)175, (01)00884838054196(21)280, (01)00884838054196(21)222, (01)00884838054196(21)183, (01)00884838054196(21)202, (01)00884838054196(21)164, (01)00884838054196(21)335, (01)00884838054196(21)288, (01)00884838054196(21)342, (01)00884838054196(21)306, (01)00884838054196(21)307, (01)00884838054196(21)265, (01)00884838054196(21)169, (01)00884838054196(21)203, (01)00884838054196(21)234, (01)00884838054196(21)267, (01)00884838054196(21)209, (01)00884838054196(21)284, (01)00884838054196(21)263, (01)00884838054196(21)174, (01)00884838054196(21)305, (01)00884838054196(21)246, (01)00884838054196(21)255, (01)00884838054196(21)178, (01)00884838054196(21)266, (01)00884838054196(21)187, (01)00884838054196(21)321, (01)00884838054196(21)328, (01)00884838054196(21)282, (01)00884838054196(21)184, (01)00884838054196(21)337, (01)00884838054196(21)357, (01)00884838054196(21)213, (01)00884838054196(21)293, (01)00884838054196(21)292, (01)00884838054196(21)346, (01)00884838054196(21)211, (01)00884838054196(21)144, (01)00884838054196(21)238, (01)00884838054196(21)247, (01)00884838054196(21)347, (01)00884838054196(21)188, (01)00884838054196(21)196, (01)00884838054196(21)339, (01)00884838054196(21)343, (01)00884838054196(21)256, (01)00884838054196(21)338, (01)00884838054196(21)334, (01)00884838054196(21)294, (01)00884838054196(21)345, (01)00884838054196(21)172, (01)00884838054196(21)323, (01)00884838054196(21)324, (01)00884838054196(21)189, (01)00884838054196(21)212, (01)00884838054196(21)268, (01)00884838054196(21)356, (01)00884838054196(21)244, (01)00884838054196(21)254, (01)00884838054196(21)362, (01)00884838054196(21)271, (01)00884838054196(21)186, (01)00884838054196(21)259, (01)00884838054196(21)236, (01)00884838054196(21)201, (01)00884838054196(21)275, (01)00884838054196(21)277, (01)00884838054196(21)349, (01)00884838054196(21)350, (01)00884838054196(21)348, (01)00884838054196(21)273, (01)00884838054196(21)249, (01)00884838054196(21)149, (01)00884838054196(21)148, (01)00884838054196(21)316, (01)00884838054196(21)274, (01)00884838054196(21)205, (01)00884838054196(21)270, (01)00884838054196(21)223, (01)00884838054196(21)181, (01)00884838054196(21)221, (01)00884838054196(21)245, (01)00884838054196(21)352, (01)00884838054196(21)358, (01)00884838054196(21)361, (01)00884838054196(21)228, (01)00884838054196(21)142, (01)00884838054196(21)214, (01)00884838054196(21)299, (01)00884838054196(21)114, (01)00884838054196(21)204, (01)00884838054196(21)225, (01)00884838054196(21)297, (01)00884838054196(21)182, (01)00884838054196(21)177, (01)00884838054196(21)300, (01)00884838054196(21)130, (01)00884838054196(21)210, (01)00884838054196(21)261, (01)00884838054196(21)260, (01)00884838054196(21)322, (01)00884838054196(21)360, (01)00884838054196(21)310, (01)00884838054196(21)291, (01)00884838054196(21)180, (01)00884838054196(21)287, (01)00884838054196(21)264, (01)00884838054196(21)272, (01)00884838054196(21)207, (01)00884838054196(21)239, (01)00884838054196(21)308, (01)00884838054196(21)243, (01)00884838054196(21)242, (01)00884838054196(21)218, (01)00884838054196(21)197, (01)00884838054196(21)235, (01)00884838054196(21)278, (01)00884838054196(21)250, (01)00884838054196(21)227, (01)00884838054196(21)233, (01)00884838054196(21)329, (01)00884838054196(21)296, (01)00884838054196(21)193, (01)00884838054196(21)219, (01)00884838054196(21)276, (01)00884838054196(21)326, (01)00884838054196(21)312, (01)00884838054196(21)304, (01)00884838054196(21)311, (01)00884838054196(21)199, (01)00884838054196(21)192, (01)00884838054196(21)289, (01)00884838054196(21)217, (01)00884838054196(21)355, (01)00884838054196(21)232, (01)00884838054196(21)315, (01)00884838054196(21)309, (01)00884838054196(21)171, (01)00884838054196(21)191, (01)00884838054196(21)269, (01)00884838054196(21)206, (01)00884838054196(21)330, (01)00884838054196(21)195, (01)00884838054196(21)215, (01)00884838054196(21)220, (01)00884838054196(21)198, (01)00884838054196(21)208, (01)00884838054196(21)286; 9. Allura Xper FD20; Model: 722006; UDI-DI: N/A; Serial Numbers: 2051, 1936, 518, 326, 66, 2587, 332, 249, 2274, 1496, 2183, 579, 1044, 2336, 443, 1913, 1259, 79, 939, 283, 405, 2161, 2068, 560, 1747, 1601, 479, 970, 1586, 878, 2537, 658, 384, 1469, 588, 328, 235, 381, 1536, 2504, 103, 826, 962, 169, 1197, 223, 595, 934, 1364, 972, 2567, 2042, 2380, 828, 528, 288, 1889, 1578, 1000, 942, 104, 2257, 1977, 1594, 118, 2003, 226, 1978, 333, 52, 53, 1242, 203, 521, 2427, 191, 1611, 1287, 250, 1582, 301, 1615, 1007, 01H041985, 2301, 1276, 234, 655, 914, 1302, 767, 781, 1038, 1306, 346, 8, 1524, 598, 639, 434, 687, 1580, 157, 491, 393, 621, 63, 2465, 2206, 585, 2487, 608, 1793, 884, 955, 1529, 1678, 1106, 946, 1650, 408, 1893, 380, 873, 102, 1232, 430, 1990, 1450, 957, 507, 1192, 136, 940, 274, 581, 2592, 2379, 890, 602, 280, 2493, 640, 2, 511; 10. Allura Xper FD20; Model: 722012; UDI: (01)00884838059054(21)2942, (01)00884838059054(21)2265, (01)00884838059054(21)2735, (01)00884838059054(21)2707, (01)00884838059054(21)135, (01)00884838059054(21)2740, (01)00884838059054(21)2843, (01)00884838059054(21)2835, (01)00884838059054(21)760, (01)00884838059054(21)735, (01)00884838059054(21)174, (01)00884838059054(21)2855, (01)00884838059054(21)2856, (01)00884838059054(21)2712, (01)00884838059054(21)606, (01)00884838059054(21)2721, (01)00884838059054(21)2085, (01)00884838059054(21)695, (01)00884838059054(21)2202, (01)00884838059054(21)2828, (01)00884838059054(21)601, (01)00884838059054(21)1207, (01)00884838059054(21)2898, (01)00884838059054(21)334, (01)00884838059054(21)1656, (01)00884838059054(21)483, (01)00884838059054(21)2305, (01)00884838059054(21)2896, (01)00884838059054(21)2726, (01)00884838059054(21)2722, (01)00884838059054(21)451, (01)00884838059054(21)2883, (01)00884838059054(21)2755, (01)00884838059054(21)2741, (01)00884838059054(21)1301, (01)00884838059054(21)2736, (01)00884838059054(21)782, (01)00884838059054(21)2890, (01)00884838059054(21)2829, (01)00884838059054(21)1675, (01)00884838059054(21)412, (01)00884838059054(21)320, (01)00884838059054(21)1224, (01)00884838059054(21)453, (01)00884838059054(21)1964, (01)00884838059054(21)325, (01)00884838059054(21)2742, (01)00884838059054(21)2889, (01)00884838059054(21)2713, (01)00884838059054(21)2899, (01)00884838059054(21)1272, (01)00884838059054(21)2857, (01)00884838059054(21)2886, (01)00884838059054(21)100, (01)00884838059054(21)2875, (01)00884838059054(21)2888, (01)00884838059054(21)71, (01)00884838059054(21)1807, (01)00884838059054(21)418, (01)00884838059054(21)1329, (01)00884838059054(21)2873, (01)00884838059054(21)1075, (01)00884838059054(21)2842, (01)00884838059054(21)2841, (01)00884838059054(21)2849, (01)00884838059054(21)2840, (01)00884838059054(21)2901, (01)00884838059054(21)1226, (01)00884838059054(21)2774, (01)00884838059054(21)1441, (01)00884838059054(21)2723, (01)00884838059054(21)2900, (01)00884838059054(21)316, (01)00884838059054(21)2892, (01)00884838059054(21)527, (01)00884838059054(21)2876, (01)00884838059054(21)2881, (01)00884838059054(21)525, (01)00884838059054(21)1806, (01)00884838059054(21)2844, (01)00884838059054(21)1712, (01)00884838059054(21)2760, (01)00884838059054(21)2868, (01)00884838059054(21)2869, (01)00884838059054(21)718, (01)00884838059054(21)1282, (01)00884838059054(21)1946, (01)00884838059054(21)2912, (01)00884838059054(21)1622, (01)00884838059054(21)2874, (01)00884838059054(21)351, (01)00884838059054(21)1655, (01)00884838059054(21)2282, (01)00884838059054(21)2891, (01)00884838059054(21)2764, (01)00884838059054(21)2880, (01)00884838059054(21)1171, (01)00884838059054(21)1921, (01)00884838059054(21)2838, (01)00884838059054(21)2887, (01)00884838059054(21)2567, (01)00884838059054(21)2703, (01)00884838059054(21)2759, (01)00884838059054(21)2945, (01)00884838059054(21)1747, (01)00884838059054(21)2879, (01)00884838059054(21)2335, (01)00884838059054(21)2913, (01)00884838059054(21)537, (01)00884838059054(21)2897, (01)00884838059054(21)288, (01)00884838059054(21)191, (01)00884838059054(21)2917, (01)00884838059054(21)2915, (01)00884838059054(21)2850, (01)00884838059054(21)2825, (01)00884838059054(21)2579, (01)00884838059054(21)2916, (01)00884838059054(21)2667, (01)00884838059054(21)2681, (01)00884838059054(21)2784, (01)00884838059054(21)2747, (01)00884838059054(21)2914, (01)00884838059054(21)1911, (01)00884838059054(21)2831, (01)00884838059054(21)2749, (01)00884838059054(21)2801, (01)00884838059054(21)2771, (01)00884838059054(21)2724, (01)00884838059054(21)2877, (01)00884838059054(21)2788, (01)00884838059054(21)2702, (01)00884838059054(21)465, (01)00884838059054(21)309, (01)00884838059054(21)2827, (01)00884838059054(21)2806, (01)00884838059054(21)1628, (01)00884838059054(21)2934, (01)00884838059054(21)2763, (01)00884838059054(21)2810, (01)00884838059054(21)2581, (01)00884838059054(21)2623, (01)00884838059054(21)2647, (01)00884838059054(21)2854, (01)00884838059054(21)2548, (01)00884838059054(21)2745, (01)00884838059054(21)2812, (01)00884838059054(21)2676, (01)00884838059054(21)2599, (01)00884838059054(21)2789, (01)00884838059054(21)2818, (01)00884838059054(21)2678, (01)00884838059054(21)2701, (01)00884838059054(21)2756, (01)00884838059054(21)1256, (01)00884838059054(21)2830, (01)00884838059054(21)982, (01)00884838059054(21)2565, (01)00884838059054(21)2752, (01)00884838059054(21)2811, (01)00884838059054(21)2852, (01)00884838059054(21)2671, (01)00884838059054(21)2649, (01)00884838059054(21)2698, (01)00884838059054(21)2661, (01)00884838059054(21)2690, (01)00884838059054(21)2775, (01)00884838059054(21)2773, (01)00884838059054(21)2834, (01)00884838059054(21)2720, (01)00884838059054(21)2626, (01)00884838059054(21)2823, (01)00884838059054(21)374, (01)00884838059054(21)2782, (01)00884838059054(21)2766, (01)00884838059054(21)2776, (01)00884838059054(21)2826, (01)00884838059054(21)2738, (01)00884838059054(21)2851, (01)00884838059054(21)2777, (01)00884838059054(21)2739, (01)00884838059054(21)2847, (01)00884838059054(21)2832, (01)00884838059054(21)2725, (01)00884838059054(21)2650, (01)00884838059054(21)2813, (01)00884838059054(21)998, (01)00884838059054(21)2744, (01)00884838059054(21)2797, (01)00884838059054(21)2229, (01)00884838059054(21)2228, (01)00884838059054(21)2781, (01)00884838059054(21)2853, (01)00884838059054(21)2716, (01)00884838059054(21)2808, (01)00884838059054(21)2837, (01)00884838059054(21)2768, (01)00884838059054(21)2673, (01)00884838059054(21)2674, (01)00884838059054(21)2803, (01)00884838059054(21)2732, (01)00884838059054(21)2798, (01)00884838059054(21)2786, (01)00884838059054(21)2778, (01)00884838059054(21)2559, (01)00884838059054(21)2746, (01)00884838059054(21)2770, (01)00884838059054(21)2691, (01)00884838059054(21)2762, (01)00884838059054(21)2729, (01)00884838059054(21)2750, (01)00884838059054(21)2804, (01)00884838059054(21)2751, (01)00884838059054(21)2640, (01)00884838059054(21)2730, (01)00884838059054(21)2562, (01)00884838059054(21)2795, (01)00884838059054(21)2718, (01)00884838059054(21)2682, (01)00884838059054(21)2574, (01)00884838059054(21)2779, (01)00884838059054(21)2711, (01)00884838059054(21)2758, (01)00884838059054(21)2836, (01)00884838059054(21)2733, (01)00884838059054(21)2824, (01)00884838059054(21)2715, (01)00884838059054(21)2704, (01)00884838059054(21)2734, (01)00884838059054(21)2793, (01)00884838059054(21)2792, (01)00884838059054(21)2566, (01)00884838059054(21)2757, (01)00884838059054(21)2765, (01)00884838059054(21)2785, (01)00884838059054(21)2767, (01)00884838059054(21)2794, (01)00884838059054(21)240, (01)00884838059054(21)2719, (01)00884838059054(21)2708, (01)00884838059054(21)2882, (01)00884838059054(21)2169, (01)00884838059054(21)2802, (01)00884838059054(21)2761, (01)00884838059054(21)2799, (01)00884838059054(21)2652, (01)00884838059054(21)2743, (01)00884838059054(21)2790, (01)00884838059054(21)2748, (01)00884838059054(21)2911, (01)00884838059054(21)2714, (01)00884838059054(21)2688, (01)00884838059054(21)2780, (01)00884838059054(21)2791, (01)00884838059054(21)1547, (01)00884838059054(21)2772, (01)00884838059054(21)657; 11. Allura Xper FD20; Model: 722028; UDI: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838054202(21)1956, (01)00884838054202(21)2206, (01)00884838054202(21)1233, (01)00884838054202(21)928, (01)00884838054202(21)2502, (01)00884838054202(21)1774, (01)00884838054202(21)869, (01)00884838054202(21)1017, (01)00884838054202(21)1957, (01)00884838054202(21)2261, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838054202(21)1043, (01)00884838054202(21)1077, (01)00884838054202(21)995, (01)00884838054202(21)896, (01)00884838054202(21)877, (01)00884838054202(21)1439, (01)00884838054202(21)1343, (01)00884838054202(21)895, (01)00884838054202(21)1154, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)1716, (01)00884838054202(21)1983, (01)00884838054202(21)2061, (01)00884838054202(21)1393, (01)00884838054202(21)1656, (01)00884838054202(21)1461, (01)00884838054202(21)1751, (01)00884838054202(21)1050, (01)00884838054202(21)1428, (01)00884838054202(21)1094, (01)00884838054202(21)2173, (01)00884838054202(21)1214, (01)00884838054202(21)52, (01)00884838054202(21)994, (01)00884838054202(21)1213, (01)00884838054202(21)1836, (01)00884838054202(21)982, (01)00884838054202(21)1646, (01)00884838054202(21)1396, (01)00884838054202(21)1394, (01)00884838054202(21)1650, (01)00884838054202(21)2275, (01)00884838054202(21)1058, (01)00884838054202(21)1353,
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2931-2026 | Class II | Philips Azurion Rystem, Model Numbers: 722063... | Jul 16, 2026 |
| Z-2932-2026 | Class II | Philips Azurion, Model Numbers: 722229, 722230... | Jul 16, 2026 |
| Z-2928-2026 | Class II | Allura Xper FD. Model Numbers: 722026, 722027, ... | Jun 29, 2026 |
| Z-2892-2026 | Class II | Philips Azurion under the following System Desc... | Jun 17, 2026 |
| Z-2891-2026 | Class II | Philips Allura under the following System Descr... | 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.