Philips Azurion 7 M12 recalled by Philips Medical Systems Nederl

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

1. Model Number: 722078. UDI Numbers: (01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)293, (01)00884838085251(21)613, (01)00884838085251(21)546, (01)00884838085251(21)479, (01)00884838085251(21)278, (01)00884838085251(21)456, (01)00884838085251(21)571, (01)00884838085251(21)921, (01)00884838085251(21)165, (01)00884838085251(21)656, (01)00884838085251(21)657, (01)00884838085251(21)576, (01)00884838085251(21)121, (01)00884838085251(21)383, (01)00884838085251(21)239, (01)00884838085251(21)645, (01)00884838085251(21)379, (01)00884838085251(21)399, (01)00884838085251(21)803, (01)00884838085251(21)296, (01)00884838085251(21)559, (01)00884838085251(21)538, (01)00884838085251(21)166, (01)00884838085251(21)257, (01)00884838085251(21)258, (01)00884838085251(21)684, (01)00884838085251(21)359, (01)00884838085251(21)143, (01)00884838085251(21)661, (01)00884838085251(21)520, (01)00884838085251(21)187, (01)00884838085251(21)269, (01)00884838085251(21)522, (01)00884838085251(21)677, 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(01)00884838085251(21)541, (01)00884838085251(21)1025, (01)00884838085251(21)672, (01)00884838085251(21)912, (01)00884838085251(21)578, (01)00884838085251(21)504, (01)00884838085251(21)398, (01)00884838085251(21)743, (01)00884838085251(21)729, (01)00884838085251(21)449, (01)00884838085251(21)429, (01)00884838085251(21)757, (01)00884838085251(21)818, (01)00884838085251(21)419, (01)00884838085251(21)328, (01)00884838085251(21)223, (01)00884838085251(21)584, (01)00884838085251(21)468, (01)00884838085251(21)855, (01)00884838085251(21)918, (01)00884838085251(21)919, (01)00884838085251(21)277, (01)00884838085251(21)976, (01)00884838085251(21)577, (01)00884838085251(21)498, (01)00884838085251(21)574, (01)00884838085251(21)27, (01)00884838085251(21)451, (01)00884838085251(21)428, (01)00884838085251(21)175, (01)00884838085251(21)460, (01)00884838085251(21)459, (01)00884838085251(21)718, (01)00884838085251(21)944, (01)00884838085251(21)669, (01)00884838085251(21)112, (01)00884838085251(21)338, 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(01)00884838085251(21)989, (01)00884838085251(21)987, (01)00884838085251(21)907, (01)00884838085251(21)1085, (01)00884838085251(21)1048, (01)00884838085251(21)1059, (01)00884838085251(21)1061, (01)00884838085251(21)1034, (01)00884838085251(21)1080, (01)00884838085251(21)875, (01)00884838085251(21)1026, (01)00884838085251(21)717, (01)00884838085251(21)716, (01)00884838085251(21)1015, (01)00884838085251(21)1045, (01)00884838085251(21)946, (01)00884838085251(21)942, (01)00884838085251(21)945, (01)00884838085251(21)947, (01)00884838085251(21)940, (01)00884838085251(21)948, (01)00884838085251(21)1052, (01)00884838085251(21)971, (01)00884838085251(21)994, (01)00884838085251(21)701, (01)00884838085251(21)1075, (01)00884838085251(21)1046, (01)00884838085251(21)970, (01)00884838085251(21)985, (01)00884838085251(21)798, (01)00884838085251(21)710, (01)00884838085251(21)1011, (01)00884838085251(21)1065, (01)00884838085251(21)1067, (01)00884838085251(21)1064, (01)00884838085251(21)1066, (01)00884838085251(21)1056, (01)00884838085251(21)992, (01)00884838085251(21)663, (01)00884838085251(21)1057, (01)00884838085251(21)965, (01)00884838085251(21)964, (01)00884838085251(21)1043, (01)00884838085251(21)736, (01)00884838085251(21)735, (01)00884838085251(21)819, (01)00884838085251(21)820, (01)00884838085251(21)1049, (01)00884838085251(21)381, (01)00884838085251(21)624, (01)00884838085251(21)775, (01)00884838085251(21)776, (01)00884838085251(21)421, (01)00884838085251(21)760, (01)00884838085251(21)614, (01)00884838085251(21)864, (01)00884838085251(21)837, (01)00884838085251(21)458, (01)00884838085251(21)281, (01)00884838085251(21)659, (01)00884838085251(21)991, (01)00884838085251(21)28, (01)00884838085251(21)29, (01)00884838085251(21)103, (01)00884838085251(21)126, (01)00884838085251(21)778, (01)00884838085251(21)363, (01)00884838085251(21)472, (01)00884838085251(21)39, (01)00884838085251(21)782, (01)00884838085251(21)961, (01)00884838085251(21)33, (01)00884838085251(21)643, (01)00884838085251(21)857, (01)00884838085251(21)636, (01)00884838085251(21)447, (01)00884838085251(21)619, (01)00884838085251(21)527, (01)00884838085251(21)600, (01)00884838085251(21)434, (01)00884838085251(21)892, (01)00884838085251(21)124, (01)00884838085251(21)201, (01)00884838085251(21)495, (01)00884838085251(21)515, (01)00884838085251(21)303, (01)00884838085251(21)304, (01)00884838085251(21)518, (01)00884838085251(21)46, (01)00884838085251(21)616, (01)00884838085251(21)972, (01)00884838085251(21)1032, (01)00884838085251(21)1051, (01)00884838085251(21)575, (01)00884838085251(21)939, (01)00884838085251(21)869, (01)00884838085251(21)874, (01)00884838085251(21)871, (01)00884838085251(21)1010, (01)00884838085251(21)1029, (01)00884838085251(21)1030, (01)00884838085251(21)18, (01)00884838085251(21)551, (01)00884838085251(21)1013, (01)00884838085251(21)543, (01)00884838085251(21)516, (01)00884838085251(21)416, (01)00884838085251(21)446, (01)00884838085251(21)685, (01)00884838085251(21)715, (01)00884838085251(21)913, (01)00884838085251(21)582, (01)00884838085251(21)908, (01)00884838085251(21)435, (01)00884838085251(21)508, (01)00884838085251(21)530, (01)00884838085251(21)198. Serial Numbers: 302, 585, 293, 613, 546, 479, 278, 456, 571, 921, 165, 656, 657, 576, 121, 383, 239, 645, 379, 399, 803, 296, 559, 538, 166, 257, 258, 684, 359, 143, 661, 520, 187, 269, 522, 677, 709, 535, 170, 723, 298, 305, 725, 728, 524, 290, 384, 360, 906, 294, 240, 603, 719, 163, 271, 412, 627, 748, 497, 483, 309, 232, 635, 612, 205, 206, 204, 218, 444, 986, 135, 589, 977, 380, 356, 344, 343, 943, 898, 482, 764, 772, 770, 771, 773, 191, 982, 981, 980, 235, 139, 511, 178, 179, 526, 265, 264, 266, 746, 287, 1003, 897, 960, 1036, 375, 374, 142, 934, 835, 975, 929, 836, 681, 1072, 1070, 1069, 1071, 893, 382, 324, 849, 347, 346, 648, 1058, 1068, 339, 340, 688, 687, 20, 846, 424, 800, 838, 156, 150, 485, 726, 727, 1039, 962, 769, 570, 698, 683, 541, 1025, 672, 912, 578, 504, 398, 743, 729, 449, 429, 757, 818, 419, 328, 223, 584, 468, 855, 918, 919, 277, 976, 577, 498, 574, 27, 451, 428, 175, 460, 459, 718, 944, 669, 112, 338, 440, 181, 920, 336, 226, 990, 839, 354, 957, 471, 357, 789, 140, 878, 988, 30, 806, 950, 652, 349, 1005, 236, 831, 501, 841, 905, 682, 843, 830, 323, 315, 680, 365, 14, 675, 369, 615, 352, 193, 280, 667, 749, 407, 505, 408, 157, 752, 138, 463, 461, 252, 169, 650, 426, 442, 351, 968, 529, 750, 259, 579, 926, 597, 899, 978, 418, 909, 601, 1033, 1035, 1009, 1047, 984, 989, 987, 907, 1085, 1048, 1059, 1061, 1034, 1080, 875, 1026, 717, 716, 1015, 1045, 946, 942, 945, 947, 940, 948, 1052, 971, 994, 701, 1075, 1046, 970, 985, 798, 710, 1011, 1065, 1067, 1064, 1066, 1056, 992, 663, 1057, 965, 964, 1043, 736, 735, 819, 820, 1049, 381, 624, 775, 776, 421, 760, 614, 864, 837, 458, 281, 659, 991, 28, 29, 103, 126, 778, 363, 472, 39, 782, 961, 33, 643, 857, 636, 447, 619, 527, 600, 434, 892, 124, 201, 495, 515, 303, 304, 518, 46, 616, 972, 1032, 1051, 575, 939, 869, 874, 871, 1010, 1029, 1030, 18, 551, 1013, 543, 516, 416, 446, 685, 715, 913, 582, 908, 435, 508, 530, 198. 2. Model Number: 722223. UDI Numbers: (01)00884838099241(21)533, (01)00884838099241(21)1146, (01)00884838099241(21)1138, (01)00884838099241(21)77, (01)00884838099241(21)439, (01)00884838099241(21)1088, (01)00884838099241(21)799, (01)00884838099241(21)1060, (01)00884838099241(21)1107, (01)00884838099241(21)261, (01)00884838099241(21)1231, (01)00884838099241(21)87, (01)00884838099241(21)746, (01)00884838099241(21)883, (01)00884838099241(21)889, (01)00884838099241(21)665, (01)00884838099241(21)1323, (01)00884838099241(21)52, (01)00884838099241(21)105, (01)00884838099241(21)96, (01)00884838099241(21)211, (01)00884838099241(21)1211, (01)00884838099241(21)161, (01)00884838099241(21)1296, (01)00884838099241(21)835, (01)00884838099241(21)130, (01)00884838099241(21)1150, (01)00884838099241(21)888, (01)00884838099241(21)435, (01)00884838099241(21)119, (01)00884838099241(21)680, (01)00884838099241(21)1131, (01)00884838099241(21)1115, (01)00884838099241(21)348, (01)00884838099241(21)1325, (01)00884838099241(21)132, 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Serial Numbers: 533, 1146, 1138, 77, 439, 1088, 799, 1060, 1107, 261, 1231, 87, 746, 883, 889, 665, 1323, 52, 105, 96, 211, 1211, 161, 1296, 835, 130, 1150, 888, 435, 119, 680, 1131, 1115, 348, 1325, 132, 814, 836, 1214, 812, 904, 1167, 1232, 875, 591, 587, 1248, 322, 756, 1016, 1256, 694, 537, 1055, 134, 1222, 434, 615, 393, 550, 612, 848, 918, 518, 683, 302, 1033, 137, 482, 919, 868, 446, 823, 1284, 1104, 719, 480, 522, 520, 521, 525, 526, 524, 519, 858, 523, 821, 862, 723, 1041, 78, 202, 760, 535, 40, 8, 492, 1207, 1301, 635, 924, 437, 438, 436, 1327, 331, 1267, 1246, 270, 468, 376, 505, 851, 894, 800, 64, 179, 445, 791, 807, 1275, 257, 266, 1336, 460, 554, 194, 954, 1151, 684, 1092, 48, 583, 413, 600, 1190, 664, 666, 419, 30, 787, 685, 1141, 773, 443, 82, 860, 278, 534, 1073, 613, 1270, 1122, 1124, 1274, 692, 766, 652, 900, 614, 517, 1172, 991, 990, 1176, 1304, 687, 689, 688, 686, 1171, 634, 1347, 1198, 1334, 843, 651, 782, 987, 1322, 1321, 1225, 762, 758, 763, 764, 765, 767, 953, 644, 1228, 421, 662, 655, 255, 536, 74, 80, 72, 625, 1007, 241, 656, 407, 24, 1026, 578, 808, 305, 1340, 1338, 1341, 983, 1009, 1209, 1335, 1201, 182, 958, 510, 1208, 1260, 320, 319, 300, 276, 493, 1062, 653.

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, 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, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.