Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-2228-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura system

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported May 27, 2026 · 1 month ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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);

Lot / code information

Model
722001
UDI
N/A
Serial #
170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F
Model
722002
UDI
N/A
Serial #
0, 81, 47; 3. Allura Xper FD10
Model
722003
UDI
N/A
Serial #
208, 392, 109, 45, 1953, 1471 — +61 moreShow all
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
Show 17 more code fields
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 — +49 moreShow all
(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 — +580 moreShow all
(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(2 …
Model
722005
UDI
N/A:
Serial #
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 — +7 moreShow all
(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 — +148 moreShow all
(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
N/A
Serial #
2051, 1936, 518, 326, 66, 2587 — +139 moreShow all
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 — +251 moreShow all
(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)00884838 …
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 — +43 moreShow all
(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
Additional code information

(01)00884838054202(21)1466, (01)00884838054202(21)1340, (01)00884838054202(21)1978, (01)00884838054202(21)431, (01)00884838054202(21)1211, (01)00884838054202(21)1651, (01)00884838054202(21)2710, (01)00884838054202(21)1326, (01)00884838054202(21)759, (01)00884838054202(21)1232, (01)00884838054202(21)925, (01)00884838054202(21)961, (01)00884838054202(21)1736, (01)00884838054202(21)1619, (01)00884838054202(21)1567, (01)00884838054202(21)1130, (01)00884838054202(21)1570, (01)00884838054202(21)1100, (01)00884838054202(21)1385, (01)00884838054202(21)1267, (01)00884838054202(21)2103, (01)00884838054202(21)1395, (01)00884838054202(21)1408, (01)00884838054202(21)741, (01)00884838054202(21)1269, (01)00884838054202(21)1837, (01)00884838054202(21)1988, (01)00884838054202(21)1051, (01)00884838054202(21)854, (01)00884838054202(21)956, (01)00884838054202(21)2020, (01)00884838054202(21)2601, (01)00884838054202(21)1261, (01)00884838054202(21)1835, (01)00884838054202(21)967, (01)00884838054202(21)1483, (01)00884838054202(21)2745, (01)00884838054202(21)2249, (01)00884838054202(21)1311, (01)00884838054202(21)1103, (01)00884838054202(21)2645, (01)00884838054202(21)678, (01)00884838054202(21)1116, (01)00884838054202(21)1880, (01)00884838054202(21)911, (01)00884838054202(21)2192, (01)00884838054202(21)1171, (01)00884838054202(21)1498, (01)00884838054202(21)1156, (01)00884838054202(21)1279, (01)00884838054202(21)1708, (01)00884838054202(21)1710, (01)00884838054202(21)664, (01)00884838054202(21)906, (01)00884838054202(21)1155, (01)00884838054202(21)1085, (01)00884838054202(21)1946, (01)00884838054202(21)1834, (01)00884838054202(21)1652, (01)00884838054202(21)1011, (01)00884838054202(21)1508, (01)00884838054202(21)2293, (01)00884838054202(21)1890, (01)00884838054202(21)654, (01)00884838054202(21)1484, (01)00884838054202(21)1995, (01)00884838054202(21)1456, (01)00884838054202(21)1288, (01)00884838054202(21)1556, (01)00884838054202(21)1201, (01)00884838054202(21)1129, (01)00884838054202(21)976, (01)00884838054202(21)2641, (01)00884838054202(21)2348, (01)00884838054202(21)922, (01)00884838054202(21)973, (01)00884838054202(21)1068, (01)00884838054202(21)1069, (01)00884838054202(21)1931, (01)00884838054202(21)2253, (01)00884838054202(21)1870, (01)00884838054202(21)1095, (01)00884838054202(21)892, (01)00884838054202(21)2295, (01)00884838054202(21)2071, (01)00884838054202(21)1327, (01)00884838054202(21)1099, (01)00884838054202(21)1407, (01)00884838054202(21)1920, (01)00884838054202(21)2709, (01)00884838054202(21)2707, (01)00884838054202(21)2174, (01)00884838054202(21)1275, (01)00884838054202(21)1142, (01)00884838054202(21)1111, (01)00884838054202(21)1122, (01)00884838054202(21)2151, (01)00884838054202(21)1352, (01)00884838054202(21)888, (01)00884838054202(21)1755, (01)00884838054202(21)1855, (01)00884838054202(21)842, (01)00884838054202(21)840, (01)00884838054202(21)2310, (01)00884838054202(21)655, (01)00884838054202(21)2007, (01)00884838054202(21)2008, (01)00884838054202(21)968, (01)00884838054202(21)781, (01)00884838054202(21)774, (01)00884838054202(21)1850, (01)00884838054202(21)1522, (01)00884838054202(21)1448, (01)00884838054202(21)1413, (01)00884838054202(21)1538, (01)00884838054202(21)1930, (01)00884838054202(21)535, (01)00884838054202(21)938, (01)00884838054202(21)990, (01)00884838054202(21)1081, (01)00884838054202(21)808, (01)00884838054202(21)1634, (01)00884838054202(21)1387, (01)00884838054202(21)1630, (01)00884838054202(21)989, (01)00884838054202(21)1824, (01)00884838054202(21)1481, (01)00884838054202(21)887, (01)00884838054202(21)1202, (01)00884838054202(21)2407, (01)00884838054202(21)2635, (01)00884838054202(21)1809, (01)00884838054202(21)874, (01)00884838054202(21)1049, (01)00884838054202(21)1333, (01)00884838054202(21)1264, (01)00884838054202(21)981, (01)00884838054202(21)1447, (01)00884838054202(21)1189, (01)00884838054202(21)1188, (01)00884838054202(21)696, (01)00884838054202(21)966, (01)00884838054202(21)1875, (01)00884838054202(21)1482, (01)00884838054202(21)1405, (01)00884838054202(21)930, (01)00884838054202(21)932, (01)00884838054202(21)1001, (01)00884838054202(21)1041, (01)00884838054202(21)1054, (01)00884838054202(21)1032, (01)00884838054202(21)2252, (01)00884838054202(21)1472, (01)00884838054202(21)1266, (01)00884838054202(21)917, (01)00884838054202(21)2070, (01)00884838054202(21)971, (01)00884838054202(21)1014, (01)00884838054202(21)1200, (01)00884838054202(21)1374, (01)00884838054202(21)1499, (01)00884838054202(21)1222, (01)00884838054202(21)1705, (01)00884838054202(21)1514, (01)00884838054202(21)2110, (01)00884838054202(21)867, (01)00884838054202(21)2200, (01)00884838054202(21)1783, (01)00884838054202(21)1723, (01)00884838054202(21)1350, (01)00884838054202(21)1454, (01)00884838054202(21)1098, (01)00884838054202(21)983, (01)00884838054202(21)1856, (01)00884838054202(21)978, (01)00884838054202(21)1132, (01)00884838054202(21)1187, (01)00884838054202(21)1889, (01)00884838054202(21)1076, (01)00884838054202(21)952, (01)00884838054202(21)1441, (01)00884838054202(21)1457, (01)00884838054202(21)2284, (01)00884838054202(21)1424, (01)00884838054202(21)893, (01)00884838054202(21)879, (01)00884838054202(21)1854, (01)00884838054202(21)934, (01)00884838054202(21)924, (01)00884838054202(21)1004, (01)00884838054202(21)1373, (01)00884838054202(21)1846, (01)00884838054202(21)962, (01)00884838054202(21)1984, (01)00884838054202(21)2422, (01)00884838054202(21)1949, (01)00884838054202(21)918, (01)00884838054202(21)998, (01)00884838054202(21)1463, (01)00884838054202(21)1212, (01)00884838054202(21)1191, (01)00884838054202(21)1370, (01)00884838054202(21)1002, (01)00884838054202(21)2760, (01)00884838054202(21)1600, (01)00884838054202(21)1244, (01)00884838054202(21)1030, (01)00884838054202(21)1869, (01)00884838054202(21)2196, (01)00884838054202(21)1286, (01)00884838054202(21)1828, (01)00884838054202(21)1446, (01)00884838054202(21)901, (01)00884838054202(21)1351, (01)00884838054202(21)1349, (01)00884838054202(21)1074, (01)00884838054202(21)1677, (01)00884838054202(21)908, (01)00884838054202(21)1629, (01)00884838054202(21)991, (01)00884838054202(21)422, (01)00884838054202(21)1822, (01)00884838054202(21)900, (01)00884838054202(21)914, (01)00884838054202(21)882, (01)00884838054202(21)945, (01)00884838054202(21)1136, (01)00884838054202(21)1639, (01)00884838054202(21)909, (01)00884838054202(21)2083, (01)00884838054202(21)1820, (01)00884838054202(21)1331, (01)00884838054202(21)1566, (01)00884838054202(21)1598, (01)00884838054202(21)1826, (01)00884838054202(21)1368, (01)00884838054202(21)1649, (01)00884838054202(21)1549, (01)00884838054202(21)1845, (01)00884838054202(21)1980, (01)00884838054202(21)1568, (01)00884838054202(21)929, (01)00884838054202(21)861, (01)00884838054202(21)1035, (01)00884838054202(21)1256, (01)00884838054202(21)1024, (01)00884838054202(21)428, (01)00884838054202(21)1022, (01)00884838054202(21)1811, (01)00884838054202(21)1359, (01)00884838054202(21)1945, (01)00884838054202(21)1168, (01)00884838054202(21)940, (01)00884838054202(21)1657, (01)00884838054202(21)878, (01)00884838054202(21)1572, (01)00884838054202(21)905, (01)00884838054202(21)1039, (01)00884838054202(21)942, (01)00884838054202(21)1056, (01)00884838054202(21)2347, (01)00884838054202(21)1271, (01)00884838054202(21)1363, (01)00884838054202(21)2322, (01)00884838054202(21)2589, (01)00884838054202(21)1193, (01)00884838054202(21)1873, (01)00884838054202(21)1915, (01)00884838054202(21)1280, (01)00884838054202(21)1255, (01)00884838054202(21)1830, (01)00884838054202(21)1814, (01)00884838054202(21)1390, (01)00884838054202(21)713, (01)00884838054202(21)1583, (01)00884838054202(21)1709, (01)00884838054202(21)2194, (01)00884838054202(21)2273, (01)00884838054202(21)1718, (01)00884838054202(21)1914, (01)00884838054202(21)935, (01)00884838054202(21)2545, (01)00884838054202(21)2048, (01)00884838054202(21)884, (01)00884838054202(21)1400, (01)00884838054202(21)2314, (01)00884838054202(21)1329, (01)00884838054202(21)1462, (01)00884838054202(21)1235, (01)00884838054202(21)1021, (01)00884838054202(21)1416, (01)00884838054202(21)2475, (01)00884838054202(21)2021, (01)00884838054202(21)1295, (01)00884838054202(21)1844, (01)00884838054202(21)2155, (01)00884838054202(21)1810, (01)00884838054202(21)1635, (01)00884838054202(21)1636, (01)00884838054202(21)2178, (01)00884838054202(21)2002, (01)00884838054202(21)1726, (01)00884838054202(21)2421, (01)00884838054202(21)777, (01)00884838054202(21)1332, (01)00884838054202(21)972, (01)00884838054202(21)1911, (01)00884838054202(21)2172, (01)00884838054202(21)2093, (01)00884838054202(21)2350, (01)00884838054202(21)2352, (01)00884838054202(21)2098, (01)00884838054202(21)1786, (01)00884838054202(21)2568, (01)00884838054202(21)1165, (01)00884838054202(21)1955, (01)00884838054202(21)2482, (01)00884838054202(21)1321, (01)00884838054202(21)1877, (01)00884838054202(21)1571, (01)00884838054202(21)1551, (01)00884838054202(21)812, (01)00884838054202(21)1979, (01)00884838054202(21)1287, (01)00884838054202(21)1247, (01)00884838054202(21)1857, (01)00884838054202(21)2489, (01)00884838054202(21)511, (01)00884838054202(21)1061, (01)00884838054202(21)964, (01)00884838054202(21)1006, (01)00884838054202(21)997, (01)00884838054202(21)1242, (01)00884838054202(21)1682, (01)00884838054202(21)1060, (01)00884838054202(21)1059, (01)00884838054202(21)2427, (01)00884838054202(21)1325, (01)00884838054202(21)1173, (01)00884838054202(21)1314, (01)00884838054202(21)1157, (01)00884838054202(21)1861, (01)00884838054202(21)2538, (01)00884838054202(21)2090, (01)00884838054202(21)1831, (01)00884838054202(21)2547, (01)00884838054202(21)1199, (01)00884838054202(21)2594, (01)00884838054202(21)1924, (01)00884838054202(21)1821, (01)00884838054202(21)2230, (01)00884838054202(21)2232, (01)00884838054202(21)2025, (01)00884838054202(21)2107, (01)00884838054202(21)1621, (01)00884838054202(21)1540, (01)00884838054202(21)1120, (01)00884838054202(21)2532, (01)00884838054202(21)2212, (01)00884838054202(21)1679, (01)00884838054202(21)2086, (01)00884838054202(21)1789, (01)00884838054202(21)2364, (01)00884838054202(21)1688, (01)00884838054202(21)963, (01)00884838054202(21)1878, (01)00884838054202(21)1866, (01)00884838054202(21)1562, (01)00884838054202(21)937, (01)00884838054202(21)1421, (01)00884838054202(21)1604, (01)00884838054202(21)1713, (01)00884838054202(21)1389, (01)00884838054202(21)980, (01)00884838054202(21)986, (01)00884838054202(21)1133, (01)00884838054202(21)1893, (01)00884838054202(21)2217, (01)00884838054202(21)881, (01)00884838054202(21)2372, (01)00884838054202(21)1112, (01)00884838054202(21)2351, (01)00884838054202(21)2047, (01)00884838054202(21)2481, (01)00884838054202(21)2483, (01)00884838054202(21)1328, (01)00884838054202(21)2095, (01)00884838054202(21)1695, (01)00884838054202(21)1694, (01)00884838054202(21)1007, (01)00884838054202(21)794, (01)00884838054202(21)1148, (01)00884838054202(21)1293, (01)00884838054202(21)965, (01)00884838054202(21)1259, (01)00884838054202(21)2334, (01)00884838054202(21)1775, (01)00884838054202(21)1460, (01)00884838054202(21)1819, (01)00884838054202(21)1865, (01)00884838054202(21)984, (01)00884838054202(21)1952, (01)00884838054202(21)1815, (01)00884838054202(21)912, (01)00884838054202(21)993, (01)00884838054202(21)1386, (01)00884838054202(21)1925, (01)00884838054202(21)1186, (01)00884838054202(21)1730, (01)00884838054202(21)894, (01)00884838054202(21)2066, (01)00884838054202(21)1720, (01)00884838054202(21)846, (01)00884838054202(21)844, (01)00884838054202(21)845, (01)00884838054202(21)1895, (01)00884838054202(21)1458, (01)00884838054202(21)2079, (01)00884838054202(21)1493, (01)00884838054202(21)1382, (01)00884838054202(21)813, (01)00884838054202(21)1529, (01)00884838054202(21)2028, (01)00884838054202(21)2041, (01)00884838054202(21)1218, (01)00884838054202(21)1313, (01)00884838054202(21)1254, (01)00884838054202(21)1205, (01)00884838054202(21)1637, (01)00884838054202(21)2408, (01)00884838054202(21)1517, (01)00884838054202(21 …

What the firm is doing

On April 28, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. 2. In 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. 3. Keep this 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. 4. If you experience the issue described in this letter, please report it to your local Philips representative. Actions planned by Philips IGT Systems to correct the issue Starting in Q1 2027, Philips will replace the deaeration hose in the CU3101 tube cooling unit in all affected systems. Your local Philips representative will contact you to schedule a visit to replace the deaeration hose once available.

DistributionShow details

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;

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls