PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

Hazard

Possibility of the patient falling from the table related to the mattress used on the patient table.

Details from the source

Reason for recall: Possibility of the patient falling from the table related to the mattress used on the patient table. Distribution: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecu Quantity: 1,837 units (337 US, 1500 OUS) Lot/code info: Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 00884838116764; Serial Numbers: (1) 465, 437, 438, 143, 302, 559, 170, 824, 626, 697, 278, 491, 215, 720, 612, 788, 141, 644, 279, 402, 290, 524, 415, 890, 412, 166, 136, 539, 532, 538, 291, 483, 497, 576, 500, 379, 753, 677, 709, 649, 441, 305, 289, 22, 257, 258, 187, 803, 399, 613, 121, 396, 536, 537, 488, 566, 833, 456, 478, 479, 224, 309, 719, 163, 921, 296, 364, 684, 239, 383, 249, 125, 829, 513, 376, 627, 725, 728, 611, 308, 522, 862, 1007, 661, 298, 571, 654, 656, 657, 658, 292, 844, 876, 480, 481, 410, 271, 493, 327, 550, 723, 269, 185, 902, 445, 360, 232, 425, 635, 546, 748, 294, 906, 603, 645, 870, 544, 545, 523, 520, 521, 556, 557, 558, 293, 840, 598, 384, 317, 535, 359, 700, 251, 786, 240, 256, 436, 585, 31, 165, 247, 733, 204, 205, 206, 888, 923, 195, 197, 162, 517, 218, 797, 444, 489, 222, 361, 362, 977, 30, 579, 223, 584, 618, 909, 193, 280, 962, 893, 287, 263, 174, 156, 27, 194, 953, 356, 182, 958, 847, 959, 713, 610, 325, 284, 527, 189, 614, 600, 864, 760, 490, 103, 140, 184, 506, 342, 673, 674, 675, 676, 23, 112, 750, 199, 363, 217, 151, 152, 160, 815, 695, 135, 985, 1058, 1077, 1047, 940, 942, 945, 946, 947, 948, 1008, 1032, 749, 918, 919, 989, 984, 1011, 701, 907, 1015, 735, 736, 856, 898, 1037, 1051, 1086, 1000, 987, 819, 820, 1057, 1081, 798, 992, 1036, 993, 986, 710, 1069, 1070, 1071, 1072, 971, 849, 1004, 1068, 1043, 1059, 1034, 1046, 106

UPC codes

00884838085251, 00884838099241, 00884838116764

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.