medical MODERATE Updated 2026-05-27

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura system; System Code Description (Model Numbers): Allu

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Recalled Product

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);

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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, 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(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,

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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