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RecallWatchMedical Device Safety
Class IIOngoingZ-1678-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Apr 8, 2026 · 4 months ago
Legal News Analyst ·

Reason for recall

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

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.

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

Lot / code information

UDI
00884838085268; System
Serial #
1023, 645, 646, 1013, 1387, 460 — +1713 moreShow all
1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534, 535, 536, 818, 412, 617, 246, 488, 53, 57, 905, 55, 691, 992, 809, 848, 1033, 836, 891, 1155, 466, 1157, 1395, 703559, 263, 420, 703391, 673, 297, 298, 299, 564, 838, 1032, 1117, 987, 1310, 1211, 1213, 47, 1365, 1408, 881, 774, 856, 922, 58, 471, 1012, 755, 633, 703540, 296, 703558, 574, 703336, 842, 884, 991, 753, 703493, 1086, 790, 840, 407, 408, 481, 703350, 877, 703395, 703323, 703775, 590, 709, 710, 711, 713, 716, 1216, 483, 1098, 1392, 241, 703408, 1108, 1363, 1355, 1414, 703387, 703404, 863, 350, 528, 703465, 1380, 908, 1238, 1378, 262, 598, 858, 859, 275, 703861, 520, 335, 1018, 593, 911, 480, 1410, 703329, 213, 325, 496, 887, 903, 703413, 1432, 594, 1309, 1312, 999, 1424, 465, 674, 1084, 353, 499, 1230, 813, 703508, 33, 1346, 1189, 1401, 361, 267, 403, 439, 526, 1021, 736, 1370, 608, 68, 703324, 611, 413, 414, 415, 453, 703306, 895, 703615, 587, 1297, 1399, 428, 883, 1267, 422, 758, 1040, 634, 573, 714, 274, 525, 843, 885, 1276, 1102, 703478, 1142, 792, 919, 703528, 754, 599, 1171, 1096, 1097, 766, 817, 78, 703419, 1322, 878, 1170, 1107, 703435, 703310, 944, 654, 703521, 273, 703305, 715, 703495, 1285, 854, 19, 904, 1005, 804, 703497, 730, 1400, 954, 375, 957, 697, 703332, 658, 423, 1022, 896, 897, 1411, 1430, 621, 703426, 628, 795, 272, 1007, 940, 250, 46, 1289, 605, 65, 360, 468, 472, 469, 828, 737, 925, 32, 857, 703416, 703327, 34, 1222, 1268, 1063, 703335, 769, 938, 655, 229, 738, 1204, 1311, 572, 776, 538, 797, 989, 946, 888, 393, 394, 1062, 52, 703396, 703420, 281, 939, 703407, 1219, 955, 402, 1042, 867, 868, 909, 931, 703425, 374, 459, 1282, 841, 703532, 1436, 703344, 1358, 1359, 1360, 1391, 703389, 50, 1006, 1352, 580, 581, 703309, 703383, 703510, 974, 1245, 396, 860, 326, 741, 584, 721, 216, 899, 703, 927, 928, 923, 981, 865, 1163, 416, 268, 689, 717, 497, 900, 1369, 424, 1258, 1323, 959, 447, 448, 1385, 1386, 852, 1252, 802, 915, 703379, 703402, 751, 704281, 436, 703311, 1402, 910, 866, 703418, 1242, 354, 708, 251, 703501, 1064, 1156, 1049, 342, 343, 344, 345, 1271, 631, 18, 479, 1103, 1361, 577, 1041, 1423, 29, 1043, 1270, 1250, 805, 930, 1200, 228, 30, 366, 543, 588, 355, 356, 357, 358, 359, 1090, 445, 703314, 945, 1226, 1232, 1236, 1237, 853, 801, 1187, 222, 247, 474, 62, 70, 703450, 537, 48, 351, 777, 41, 898, 703317, 653, 684, 703334, 912, 746, 703368, 703562, 54, 1231, 731, 540, 998, 618, 1179, 703360, 1283, 668, 1431, 607, 706, 847, 879, 703308, 837, 1251, 703575, 387, 417, 1316, 45, 1393, 1290, 334, 320, 429, 212, 290, 703409, 239, 669, 703390, 629, 1078, 800, 56, 703584, 470, 595, 64, 671, 793, 1059, 1381, 1382, 747, 585, 1246, 663, 1212, 703333, 1274, 255, 455, 637, 862, 1379, 1235, 810, 1164, 227, 437, 438, 703345, 990, 314, 613, 427, 60, 1100, 703486, 602, 318, 937, 703515, 703455, 703456, 703457, 942, 948, 1201, 1247, 702, 333, 703388, 644, 845, 846, 1415, 1000, 814, 284, 352, 703356, 703380, 703381, 265, 679, 328, 329, 330, 331, 332, 1017, 1039, 1374, 750, 1016, 783, 703550, 703685, 703551, 703813, 704301, 780, 703719, 217, 476, 815, 816, 214, 703565, 1280, 704304, 561, 59, 703338, 719, 894, 744, 745, 704059, 729, 943, 302, 31, 337, 703552, 703613, 704240, 704242, 703662, 1340, 549, 703838, 1037, 703823, 703670, 1026, 377, 379, 380, 1405, 258, 259, 260, 395, 433, 451, 662, 703355, 703449, 703654, 703699, 703870, 703612, 704299, 704300, 703899, 1306, 970, 1248, 822, 449, 1047, 1019, 1241, 557, 1143, 752, 704129, 558, 947, 1190, 1196, 1172, 1319, 703712, 1397, 1398, 289, 704295, 994, 703326, 703655, 703702, 703939, 531, 703802, 703897, 704203, 704266, 1389, 703953, 703986, 703600, 570, 703769, 458, 962, 703374, 703710, 704026, 703592, 215, 703384, 703392, 545, 703753, 703967, 704112, 984, 703992, 703807, 1036, 1351, 703463, 703818, 871, 703529, 1073, 704154, 778, 548, 798, 704037, 933, 316, 703669, 704290, 234, 1429, 313, 49, 704209, 722, 703619, 704142, 378, 418, 1053, 600, 825, 452, 969, 1020, 1265, 763, 703545, 703358, 1095, 703487, 704092, 461, 1239, 703867, 786, 578, 703572, 559, 560, 982, 703462, 464, 703583, 1106, 1044, 703855, 704127, 1205, 1206, 1214, 450, 703348, 252, 703872, 430, 997, 271, 312, 1338, 855, 1169, 1030, 1120, 339, 1121, 934, 1168, 1150, 699, 704199, 703489, 703959, 913, 563, 304, 1191, 567, 566, 916, 388, 707, 1195, 1193, 301, 554, 555, 704282, 704284, 1083, 703966, 303, 305, 704101, 1194, 785, 703961, 1337, 993, 688, 347, 772, 74, 632, 383, 735, 39, 1074, 230, 1182, 1341, 293, 936, 703944, 704258, 295, 675, 949, 411, 701, 287, 286, 232, 760, 421, 726, 1109, 1144, 434, 591, 61, 961, 1072, 1185, 703477, 257, 661, 704146, 703982, 1440, 1441, 1442, 389, 703438, 703783, 704211, 703812, 1122, 725, 703423, 341, 367, 37, 1317, 1192, 1264, 575, 1202, 36, 309, 67, 703824, 1278, 703313, 703544, 703393, 703428, 703713, 703815, 1372, 703330, 1347, 958, 703472, 951, 1009, 482, 1254, 300, 620, 986, 703740, 493, 484, 988, 1082, 704171, 542, 703470, 589, 552, 704277, 235, 486, 700, 348, 565, 322, 1123, 819, 703749, 782, 25, 1154, 703965, 703993, 704239, 703877, 703542, 1001, 704173, 71, 703445, 551, 550, 703526, 1186, 1104, 740, 704085, 704079, 703485, 547, 703500, 703935, 371, 835, 703436, 1203, 485, 703405, 704289, 596, 803, 703806, 1052, 703804, 703906, 703596, 1181, 224, 703937, 703972, 1288, 703954, 1183, 1217, 368, 1314, 703650, 704262, 703948, 703556, 687, 902, 1422, 571, 278, 457, 703754, 704081, 703854, 704103, 1116, 478, 682, 704019, 703995, 1119, 960, 824, 1257, 522, 523, 839, 703424, 704023, 704119, 1015, 703614, 1089, 1175, 748, 781, 1076, 1129, 532, 703347, 1166, 704030, 704126, 489, 956, 569, 432, 874, 703819, 704036, 889, 446, 914, 703690, 703597, 703866, 703611, 1080, 703375, 704269, 703648, 703709, 787, 703586, 704207, 703728, 703826, 381, 630, 638, 826, 901, 703607, 703574, 1165, 762, 703743, 703632, 703913, 703889, 703700, 704246, 704054, 703606, 703473, 703346, 521, 703750, 966, 703638, 703990, 703834, 703727, 586, 965, 703875, 1 …
UDI
00884838099258; System
Serial #
1229, 450, 1576, 1577, 1578, 750 — +2830 moreShow all
1229, 450, 1576, 1577, 1578, 750, 409, 261, 262, 272, 275, 277, 295, 630, 1003, 1315, 2744, 3526, 381, 959, 232, 1019, 1371, 260, 1049, 1484, 2258, 3044, 3045, 3107, 2573, 1083, 3514, 3314, 2184, 2436, 246, 475, 1810, 762, 3153, 526, 2241, 588, 469, 962, 539, 421, 288, 90, 1635, 2784, 50, 239, 2520, 589, 91, 1556, 2945, 840, 362, 43, 1869, 1564, 1692, 2778, 210, 44, 2421, 2432, 287, 2882, 3291, 3155, 3211, 904, 403, 1356, 1955, 1808, 2800, 2801, 1838, 2368, 951, 723, 216, 3697, 1874, 1150, 3062, 3063, 226, 2881, 790, 3042, 2434, 3374, 1266, 365, 266, 512, 954, 301, 1046, 1081, 1103, 993, 994, 958, 901, 3067, 514, 553, 2390, 832, 1569, 1636, 617, 618, 82, 753, 754, 40, 2227, 2280, 2879, 369, 1781, 1929, 3642, 2376, 527, 2972, 1025, 110, 1938, 297, 3244, 1300, 2765, 2786, 3393, 3336, 584, 1362, 1255, 1259, 859, 2971, 957, 425, 837, 1224, 1934, 611, 2929, 2759, 3490, 3582, 2856, 831, 2906, 2918, 2996, 3282, 826, 1706, 566, 2495, 742, 2201, 434, 164, 2420, 1481, 912, 2559, 2993, 3020, 2511, 2438, 3043, 224, 190, 2166, 153, 1931, 1106, 1032, 788, 789, 3302, 79, 1271, 739, 1605, 656, 609, 650, 667, 395, 2039, 2723, 182, 2504, 75, 3305, 380, 1995, 2911, 1318, 1063, 1249, 1337, 1039, 2176, 2177, 1374, 1375, 1939, 1524, 813, 814, 1382, 998, 3273, 3152, 1220, 3296, 286, 289, 1679, 613, 3510, 1234, 1064, 3046, 3048, 1693, 363, 2181, 2981, 580, 1604, 3354, 850, 1258, 1260, 1036, 1160, 1346, 1347, 1117, 1082, 273, 306, 333, 218, 2448, 1614, 2668, 547, 1625, 228, 3453, 1223, 25, 1059, 967, 2952, 391, 2121, 612, 2912, 946, 950, 2687, 2873, 191, 2433, 3158, 3450, 1009, 454, 995, 2829, 2830, 1253, 3262, 1488, 3283, 966, 3345, 1940, 2594, 3578, 2870, 886, 2656, 867, 738, 2883, 2908, 3503, 3504, 244, 1270, 1518, 360, 229, 2793, 1975, 428, 3564, 2722, 2311, 476, 1559, 238, 42, 968, 1334, 1924, 1926, 2145, 166, 2831, 2331, 56, 3362, 105, 2901, 291, 444, 817, 2058, 640, 298, 2980, 240, 1516, 876, 94, 564, 33, 856, 1245, 385, 2524, 2532, 2503, 3376, 715, 1047, 461, 2135, 41, 577, 129, 2969, 432, 439, 603, 2449, 1038, 595, 792, 2979, 3007, 713, 741, 401, 2595, 400, 3373, 415, 1317, 3398, 963, 965, 1228, 2308, 1265, 2995, 3120, 3123, 3179, 1510, 178, 494, 1662, 2316, 571, 2619, 2620, 151, 554, 1574, 892, 1174, 657, 115, 274, 3145, 3146, 1357, 215, 674, 1086, 1093, 1279, 1329, 3038, 342, 282, 1554, 865, 138, 478, 516, 770, 187, 871, 873, 49, 154, 1482, 1783, 2229, 2246, 2247, 2248, 278, 2764, 433, 1168, 2727, 3525, 2522, 2523, 1175, 1395, 552, 964, 1571, 624, 354, 885, 189, 1994, 1100, 217, 2839, 192, 3130, 2502, 755, 3210, 3486, 3603, 108, 1278, 373, 2154, 339, 471, 103, 947, 1140, 825, 1519, 234, 47, 1615, 1637, 1651, 1657, 1925, 665, 637, 2846, 1264, 3341, 1606, 1612, 1613, 3219, 3337, 338, 3541, 1490, 2569, 128, 1101, 1118, 2974, 3588, 1012, 1467, 2913, 265, 1158, 2435, 1960, 2045, 119, 446, 483, 484, 696, 2860, 1252, 869, 1376, 1377, 1514, 1550, 2185, 3023, 2900, 587, 1985, 3178, 1839, 2740, 436, 438, 608, 2140, 2141, 112, 2548, 1257, 1037, 1739, 464, 335, 841, 326, 134, 3515, 453, 893, 1540, 507, 2675, 147, 148, 1565, 447, 107, 2754, 1018, 2377, 1879, 1004, 1214, 417, 374, 396, 482, 730, 1486, 3016, 2572, 1405, 163, 1230, 492, 233, 1935, 2226, 3492, 2567, 2332, 2533, 3132, 3147, 583, 3269, 662, 836, 78, 1663, 267, 268, 346, 1555, 2239, 1276, 3384, 443, 1782, 2439, 2452, 252, 3224, 2281, 3090, 1436, 1653, 2609, 1525, 2718, 1246, 1256, 414, 797, 1014, 2370, 1866, 953, 763, 1563, 45, 2326, 543, 1244, 2195, 2196, 3085, 651, 1459, 285, 308, 540, 351, 1024, 2221, 1394, 1381, 2717, 1111, 2453, 2501, 3509, 300, 100, 591, 140, 1309, 1310, 2172, 2720, 952, 479, 2647, 735, 2279, 616, 2132, 1079, 2220, 594, 857, 973, 2579, 1526, 3165, 370, 437, 599, 1702, 3328, 3333, 3274, 251, 2859, 3615, 2228, 3172, 1956, 2869, 2939, 1299, 124, 125, 120, 183, 2222, 366, 2737, 1041, 131, 3258, 839, 2278, 39, 999, 785, 2072, 982, 1221, 2617, 945, 3207, 1798, 3039, 1873, 1142, 88, 1215, 466, 101, 1147, 1954, 462, 2729, 3303, 99, 3516, 2143, 3176, 2963, 592, 3101, 3415, 2970, 2655, 188, 986, 106, 472, 2663, 3577, 2369, 1483, 36, 626, 2301, 312, 2130, 165, 1551, 3037, 1793, 1363, 1364, 3078, 72, 2139, 141, 956, 2152, 2876, 3539, 1383, 3026, 2965, 2967, 1999, 2000, 2001, 2425, 28, 3444, 1872, 2199, 2144, 2148, 46, 777, 177, 440, 1460, 1611, 1274, 1301, 884, 2564, 364, 746, 2340, 3161, 2403, 80, 574, 2198, 3270, 113, 644, 169, 2328, 1797, 2138, 250, 1507, 1509, 1458, 3052, 3053, 435, 3087, 1403, 194, 53, 1828, 1829, 1830, 2961, 606, 2417, 900, 332, 2636, 3414, 2427, 517, 2219, 1354, 845, 847, 2131, 254, 102, 843, 3579, 1061, 1499, 1250, 3205, 3690, 960, 290, 1336, 404, 1444, 1517, 2903, 2907, 485, 621, 622, 2288, 331, 467, 468, 3106, 974, 465, 1233, 1240, 1235, 328, 329, 139, 159, 1461, 1508, 1511, 1512, 490, 593, 3593, 2325, 2327, 1455, 2957, 279, 955, 2027, 3614, 253, 1161, 1243, 905, 3419, 3448, 2367, 1324, 2374, 307, 1959, 888, 3483, 1493, 64, 130, 1112, 1650, 3352, 2682, 116, 1689, 2669, 3157, 1251, 3454, 3527, 3668, 3489, 607, 2437, 2928, 844, 975, 1060, 2426, 327, 1775, 1776, 3189, 2018, 740, 747, 851, 852, 1547, 979, 862, 897, 3471, 3528, 3530, 3531, 787, 2919, 176, 2149, 2197, 418, 219, 1998, 1091, 1491, 1409, 582, 441, 84, 3664, 798, 823, 824, 2506, 949, 174, 2926, 350, 1468, 3673, 940, 271, 76, 1170, 3573, 761, 109, 1288, 1982, 160, 34, 786, 2494, 2699, 1000, 2557, 793, 1353, 3388, 581, 1827, 2150, 220, 2681, 225, 235, 714, 2518, 2519, 452, 1213, 1126, 2156, 766, 1254, 518, 522, 523, 726, 1311, 1314, 3299, 2770, 3401, 3049, 2030, 1316, 343, 1410, 2733, 643, 3369, 3082, 3164, 1527, 104, 1201, 503, 659, 1015, 1335, 185, 1231, 196, 944, 2752, 1247, 833, 1029, 258, 2843, 330, 172, 372, 2955, 1477, 379, 666, 585, 722, 1156, 3650, 3661, 3662, 3692, 649, 874, 875, 3596, 1787, 480, 495, 2242, 173, 2667, 1478, 2029, 3505, 3459, 2772, 2937, 1863, 780, 1622, 1089, 1341, 257, 352, 1568, 3464, 181, 1786, 623, 2852, 2931, 3293, 1764, 2742, 3474, 1988, 1974, 1851, 2787, 2804, 2933, 1627, 1629, 1632, 2777, 1008, 1709, 497, 3497, 1163, 578, 2550, …
UDI
00884838116771; System
Serial #
163, 327, 780, 362, 502, 222 — +515 moreShow all
163, 327, 780, 362, 502, 222, 803, 347, 161, 84, 352, 287, 212, 322, 88, 716, 185, 426, 292, 43, 252, 59, 60, 332, 97, 359, 346, 383, 300, 804, 340, 711, 186, 99, 413, 547, 449, 335, 437, 813, 447, 358, 510, 511, 404, 484, 626, 216, 207, 248, 175, 87, 333, 395, 55, 68, 655, 459, 71, 465, 274, 330, 501, 535, 463, 320, 218, 817, 483, 516, 616, 461, 475, 270, 762, 617, 178, 171, 198, 331, 123, 124, 726, 162, 774, 85, 284, 67, 94, 469, 696, 471, 607, 606, 758, 260, 619, 267, 269, 489, 255, 628, 629, 730, 637, 639, 640, 633, 92, 345, 874, 257, 101, 493, 772, 560, 168, 79, 155, 372, 714, 797, 794, 565, 225, 286, 657, 585, 638, 779, 233, 620, 432, 433, 208, 435, 309, 418, 689, 524, 256, 159, 852, 768, 580, 796, 223, 98, 107, 409, 209, 442, 266, 194, 624, 411, 698, 253, 54, 76, 108, 70, 165, 329, 122, 450, 403, 348, 288, 77, 263, 174, 321, 262, 877, 519, 467, 520, 509, 133, 515, 119, 485, 460, 853, 191, 500, 586, 217, 492, 201, 554, 232, 140, 344, 183, 667, 419, 827, 139, 674, 538, 675, 420, 102, 462, 662, 430, 514, 319, 334, 416, 513, 641, 324, 767, 187, 111, 719, 839, 275, 750, 706, 482, 534, 821, 438, 691, 412, 42, 873, 682, 385, 679, 939, 941, 45, 625, 582, 964, 37, 795, 78, 177, 401, 295, 486, 408, 205, 737, 114, 261, 424, 850, 683, 503, 36, 46, 678, 851, 709, 494, 757, 578, 755, 961, 27, 981, 316, 745, 421, 632, 945, 259, 264, 307, 82, 353, 701, 868, 566, 567, 720, 733, 739, 91, 134, 296, 190, 304, 106, 30, 570, 192, 722, 764, 93, 158, 103, 120, 415, 928, 869, 846, 143, 224, 180, 238, 908, 688, 282, 464, 756, 64, 66, 83, 90, 131, 179, 53, 588, 200, 243, 302, 56, 499, 910, 751, 761, 16, 690, 920, 455, 888, 562, 702, 552, 599, 558, 40, 15, 473, 544, 504, 468, 645, 448, 399, 523, 51, 612, 181, 182, 579, 96, 235, 236, 237, 953, 1022, 506, 933, 310, 634, 414, 487, 495, 400, 876, 95, 754, 481, 313, 277, 278, 983, 497, 498, 508, 782, 792, 826, 39, 337, 250, 281, 195, 491, 21, 776, 341, 614, 763, 631, 589, 692, 775, 242, 820, 658, 759, 627, 490, 687, 137, 138, 314, 635, 308, 41, 245, 149, 65, 665, 721, 38, 145, 1017, 651, 445, 650, 17, 743, 355, 881, 305, 148, 572, 727, 443, 12, 13, 819, 452, 254, 49, 328, 649, 105, 73, 23, 596, 611, 446, 731, 677, 837, 115, 338, 571, 439, 219, 384, 44, 132, 713, 478, 479, 480, 378, 406, 19, 724, 604, 241, 57, 742, 135, 374, 505, 303, 387, 388, 142, 802, 58, 474, 339, 239, 247, 531, 249, 364, 365, 127, 569, 47, 229, 360, 361, 425, 950, 52, 294, 840, 766, 844, 189, 18, 312, 156, 301, 152, 279, 197, 33, 871, 184, 32, 20, 31, 909, 26, 563, 29, 870, 272, 553, 746, 736, 856; (4) System Code: 722282
UDI
00884838110571; System
Serial #
57, 54, 66, 73, 32, 7 — +85 moreShow all
57, 54, 66, 73, 32, 7, 87, 55, 36, 110, 111, 112, 45, 116, 59, 81, 89, 42, 47, 48, 31, 26, 63, 83, 99, 46, 91, 39, 40, 34, 84, 114, 43, 44, 76, 28, 95, 115, 131, 9, 101, 16, 17, 51, 79, 56, 30, 121, 97, 41, 20, 33, 77, 68, 65, 98, 70, 11, 88, 126, 71, 94, 105, 24, 29, 38, 122, 25, 10, 93, 75, 113, 18, 104, 72, 21, 35, 85, 64, 69, 8, 62, 80, 82, 124, 23, 52, 53, 15, 100, 50

What the firm is doing

On March 3, 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 and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. 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. 5. Keep this Urgent Medical Device Correction 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. 6. Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken.

DistributionShow details

Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, 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.

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