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RecallWatchMedical Device Safety
Class IIOngoingZ-1676-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Apr 8, 2026 · 3 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 B20; System Code: (1)722068, (2)722226, (3)722236;

Lot / code information

UDI
00884838085367; System
Serial #
547, 178, 467, 335, 147, 205 — +414 moreShow all
547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42, 153, 324, 323, 320, 85, 89, 109, 407, 239, 505, 271, 443, 104, 370, 322, 136, 373, 442, 524, 308, 354, 75, 279, 400, 196, 510, 110, 446, 78, 330, 73, 288, 285, 295, 406, 528, 329, 184, 350, 462, 304, 457, 470, 472, 319, 520, 490, 243, 103, 479, 261, 262, 150, 277, 172, 117, 130, 356, 143, 146, 84, 251, 469, 431, 361, 76, 374, 270, 114, 511, 477, 232, 137, 282, 487, 413, 337, 101, 213, 82, 265, 275, 485, 459, 276, 62, 506, 608, 473, 417, 302, 314, 88, 126, 211, 468, 422, 454, 410, 283, 231, 548, 466, 495, 207, 167, 445, 537, 438, 173, 233, 289, 536, 192, 204, 77, 166, 313, 236, 133, 481, 280, 307, 577, 210, 258, 328, 325, 199, 480, 53, 72, 364, 491, 423, 509, 246, 614, 142, 376, 539, 257, 140, 369, 195, 500, 508, 97, 87, 303, 48, 44, 301, 550, 460, 118, 293, 551, 478, 522, 568, 448, 242, 238, 68, 160, 83, 544, 230, 434, 435, 360, 93, 36, 372, 179, 306, 182, 583, 327, 244, 382, 428, 432, 215, 447, 338, 399, 339, 316, 555, 552, 570, 347, 148, 134, 38, 560, 158, 535, 318, 518, 250, 336, 185, 206, 50, 489, 521, 37, 79, 529, 111, 254, 427, 394, 71, 47, 534, 292, 497, 591, 35, 227, 359, 527, 387, 168, 128, 129, 396, 515, 486, 543, 69, 453, 174, 483, 484, 334, 425, 181, 408, 415, 141, 365, 471, 540, 584, 553, 602, 240, 617, 604, 593, 589, 526, 559, 612, 450, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 599, 563, 590, 198, 600, 228, 380, 420, 397, 212, 475, 180, 268, 269, 414, 74, 562, 115, 349, 291, 519, 234, 219, 532, 533, 60, 398, 618, 549, 46, 96, 416, 249, 531, 426, 162, 290, 346, 49, 326, 286, 125, 102, 113, 124, 138, 362, 127, 145, 299, 317, 571, 187, 183, 45, 331, 106, 465, 281, 112, 501, 393, 116, 273, 188, 264, 139, 503, 122, 439, 135, 248, 404, 390, 263, 90, 300, 224, 67, 61, 157, 154, 100, 217, 253, 391, 144, 379, 202, 105, 226, 315, 464, 197, 63, 252, 175, 274, 163, 186, 260, 502, 152, 498, 156, 621, 296, 208, 430, 161, 436, 409, 155, 298, 191, 278, 368, 94, 66, 108, 200, 201, 98, 189, 311, 367, 297, 132, 507, 451; (2) System Code: 722226
UDI
00884838099272; System
Serial #
120, 122, 123, 124, 125, 126 — +854 moreShow all
120, 122, 123, 124, 125, 126, 127, 153, 67, 209, 271, 675, 112, 1052, 1091, 113, 121, 139, 158, 1078, 1145, 239, 105, 678, 114, 362, 758, 403, 702, 108, 545, 197, 380, 281, 688, 592, 593, 495, 319, 687, 921, 182, 183, 325, 690, 100, 272, 680, 724, 350, 891, 280, 270, 254, 107, 144, 761, 681, 691, 779, 294, 845, 559, 116, 343, 98, 301, 117, 876, 1021, 244, 332, 781, 782, 534, 341, 374, 78, 11, 441, 129, 180, 918, 442, 220, 555, 189, 190, 871, 446, 842, 255, 848, 208, 554, 955, 360, 337, 159, 400, 757, 326, 323, 175, 427, 464, 468, 778, 683, 143, 262, 482, 971, 391, 392, 173, 793, 147, 204, 467, 1017, 260, 381, 912, 410, 508, 419, 313, 472, 894, 318, 473, 383, 689, 973, 463, 823, 181, 205, 361, 59, 756, 379, 1008, 266, 1002, 398, 75, 786, 19, 1125, 213, 214, 215, 1007, 814, 969, 970, 469, 219, 462, 296, 149, 704, 573, 458, 987, 141, 711, 693, 510, 882, 226, 509, 584, 21, 1050, 647, 225, 201, 202, 303, 666, 184, 243, 178, 179, 250, 1139, 674, 1062, 575, 1121, 368, 950, 861, 176, 712, 829, 413, 997, 249, 589, 1046, 708, 738, 1083, 717, 697, 1126, 665, 416, 386, 764, 977, 595, 859, 1113, 721, 1043, 797, 957, 1006, 498, 60, 232, 423, 682, 789, 698, 331, 1097, 1094, 378, 808, 1107, 393, 949, 718, 663, 195, 411, 1092, 412, 715, 1143, 775, 1073, 982, 282, 785, 617, 958, 221, 222, 604, 430, 1027, 1067, 415, 810, 1114, 61, 1147, 314, 822, 561, 1026, 1102, 762, 306, 359, 978, 1060, 972, 83, 199, 1013, 920, 1136, 898, 835, 836, 795, 671, 799, 800, 899, 905, 838, 944, 1123, 335, 363, 1039, 731, 399, 869, 725, 701, 626, 967, 623, 744, 501, 953, 1018, 513, 533, 677, 449, 119, 367, 927, 480, 732, 974, 344, 824, 984, 487, 919, 605, 230, 523, 686, 327, 1138, 424, 684, 477, 1049, 298, 809, 10, 227, 520, 521, 522, 993, 874, 259, 140, 628, 530, 506, 909, 142, 733, 263, 490, 494, 633, 634, 396, 547, 631, 514, 642, 505, 321, 754, 17, 422, 1057, 420, 247, 99, 36, 432, 539, 88, 245, 911, 132, 133, 667, 5, 1103, 188, 586, 14, 622, 228, 4, 1069, 45, 316, 164, 485, 448, 507, 97, 351, 497, 685, 771, 790, 1076, 543, 66, 542, 550, 551, 484, 504, 714, 1054, 366, 18, 1048, 893, 1132, 217, 752, 1088, 47, 544, 148, 408, 906, 289, 548, 238, 299, 283, 284, 401, 404, 827, 833, 84, 692, 895, 118, 924, 224, 233, 1087, 579, 515, 455, 946, 599, 726, 676, 395, 670, 1, 261, 444, 826, 93, 956, 1077, 900, 901, 320, 355, 710, 435, 1072, 820, 749, 235, 846, 727, 621, 1129, 1041, 777, 1053, 274, 486, 1014, 1015, 503, 1071, 431, 481, 460, 765, 194, 696, 1099, 25, 451, 438, 275, 552, 352, 87, 630, 1047, 941, 345, 349, 429, 854, 1009, 888, 369, 557, 585, 596, 342, 457, 645, 739, 736, 1127, 963, 527, 251, 1115, 1000, 965, 553, 1042, 699, 1064, 574, 741, 748, 1137, 887, 632, 1118, 737, 1131, 1148, 1111, 907, 662, 825, 1075, 877, 1134, 1023, 648, 831, 1135, 751, 1061, 1036, 1104, 830, 1152, 860, 798, 603, 577, 938, 886, 1066, 773, 939, 1128, 1065, 1038, 716, 979, 672, 1109, 903, 549, 669, 747, 1124, 29, 817, 995, 625, 439, 297, 743, 27, 131, 643, 644, 563, 639, 640, 945, 22, 203, 333, 50, 813, 198, 168, 166, 766, 16, 580, 384, 740, 755, 1022, 207, 598, 491, 896, 54, 849, 82, 679, 330, 417, 892, 277, 278, 152, 720, 385, 641, 1020, 55, 742, 305, 832, 1059, 409, 947, 902, 867, 627, 872, 418, 489, 231, 1080, 407, 6, 1089, 913, 840, 24, 364, 307, 1035, 1055, 531, 532, 745, 1033, 791, 591, 772, 878, 86, 1093, 7, 768, 664, 85, 52, 53, 890, 63, 637, 815, 943, 729, 1079, 478, 1106, 546, 650, 26, 883, 171, 453, 889, 753, 673, 844, 276, 649, 69, 1058, 556, 528, 660, 74, 358, 855, 568, 353, 286, 317, 42, 115, 229, 285, 440, 606, 156, 908, 43, 288, 933, 161, 162, 828, 421, 818, 540, 73, 452, 405, 46, 694, 722, 583, 784, 525, 312, 570, 160, 658, 804, 216, 95, 709, 803, 39, 856, 853, 653, 502, 70, 128, 287, 40, 1032, 655, 89, 279, 851, 807, 581, 265, 237, 106, 304, 137, 110, 336, 257, 68, 841, 234, 885, 654, 64, 916, 3, 819, 192, 193, 618, 32, 292, 206, 904, 49, 541, 646, 456, 870, 258, 172, 529, 38, 866, 382, 524, 659, 33, 656, 801, 802, 290, 30, 92, 269, 240, 163, 852, 62, 1034, 436, 806, 210, 187, 264, 578, 928, 847, 90, 587, 499, 154, 273, 186, 34, 44, 65, 71, 558, 425, 196, 91, 657, 35, 356, 500, 537, 375, 567, 668, 454, 479, 31, 450, 496, 302, 80, 406, 857, 41, 770, 56, 155, 619, 177, 811, 96, 28, 560, 433, 308, 998, 324, 157, 357, 340, 588, 934, 79, 77, 476, 236, 146, 863, 165, 402, 652, 241; (3) System Code: 722236
UDI
00884838116788; System
Serial #
127, 37, 159, 345, 24, 17 — +237 moreShow all
127, 37, 159, 345, 24, 17, 25, 180, 150, 227, 235, 131, 288, 226, 231, 203, 26, 20, 249, 121, 200, 208, 42, 205, 36, 183, 81, 147, 148, 133, 31, 342, 54, 194, 43, 158, 99, 21, 40, 60, 118, 50, 378, 325, 335, 39, 191, 280, 233, 48, 197, 221, 68, 204, 51, 230, 38, 22, 186, 32, 276, 116, 134, 272, 273, 330, 357, 10, 289, 67, 242, 361, 29, 192, 223, 13, 164, 368, 353, 215, 348, 244, 322, 352, 300, 114, 383, 173, 351, 117, 376, 201, 278, 414, 271, 34, 122, 123, 374, 326, 162, 93, 245, 241, 207, 232, 380, 312, 385, 377, 216, 219, 311, 56, 57, 169, 91, 167, 44, 234, 156, 324, 375, 274, 237, 113, 46, 33, 292, 66, 165, 163, 283, 284, 285, 193, 297, 287, 347, 321, 8, 269, 102, 316, 132, 157, 224, 331, 98, 168, 189, 30, 370, 146, 125, 333, 182, 405, 27, 145, 329, 100, 23, 338, 96, 181, 188, 258, 130, 358, 154, 279, 264, 126, 128, 86, 94, 379, 160, 310, 41, 170, 82, 63, 268, 328, 277, 111, 172, 112, 259, 318, 103, 75, 84, 52, 73, 80, 175, 305, 92, 155, 55, 85, 142, 105, 108, 53, 144, 198, 141, 299, 124, 320, 62, 261, 88, 89, 109, 83, 171, 317, 240, 76, 106, 90, 251, 49, 314, 77, 74, 78, 59, 206, 104, 70, 107, 64, 151, 152, 293, 69, 153

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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