Potential safety issue where a patient may be harmed while preparing for or during a scan.
Reason for recall: Potential safety issue where a patient may be harmed while preparing for or during a scan. Distribution: US Nationwide distribution. Quantity: 5,231 units Lot/code info: REF: 453530280721, 453530280723, 459801290511, 459801290514, 459801729882; UDI: 00884838066854, 00884838086425, 00884838118393; Serial No. 482, 508, 119, 40, 318, 394, 443, 41, 286, 120, 264, 412, 426, 457, 476, 342, 154, 319, 368, 409, 176, 35, 265, 416, 392, 437, 493, 529, 500, 526, 517, 531, 533, 276, 430, 509, 333, 356, 370, 445, 510, 53, 125, 117, 268, 174, 175, 282, 310, 452, 425, 399, 389, 442, 442, 303, 505, 45, 375, 369, 321, 325, 347, 300, 377, 372, 423, 448, 470, 525, 413, 458, 385, 510, 387, 314, 327, 335, 340, 376, 447, 401, 410, 486, 487, 507, 515, 516, 2, 129, 124, 122, 264, 272, 284, 304, 311, 479, 514, 344, 349, 513, 453, 367, 512, 513, 309, 306, 313, 355, 362, 363, 406, 390, 444, 428, 451, 488, 523, 504, 532, 444, 528, 52, 27, 146, 301, 315, 281, 520, 114, 424, 336, 535, 155, 411, 449, 524, 433, 25, 128, 137, 123, 144, 300, 158, 274, 300, 302, 307, 446, 308, 160, 275, 46, 329, 359, 353, 115, 138, 348, 534, 478, 502, 358, 431, 149, 383, 354, 351, 346, 454, 527, 271, 326, 339, 371, 386, 497, 391, 435, 163, 283, 332, 405, 159, 269, 352, 459, 456, 496, 501, 330, 388, 530, 113, 148, 157, 156, 320, 176, 415, 384, 407, 145, 10, 2, 71, 54, 12, 112, 118, 64, 102, 151, 147, 150, 153, 146, 166, 273, 267, 280, 1081, 1071, 1098, 1097, 1024, 1000, 1050, 1047, 1003, 1074, 528, 1069, 1096, 1052, 510, 1072, 1088, 1030, 1089, 1070, 1073, 1087, 1085, 1001, 1017, 1082, 513, 1005, 1022, 1051, 1093, 1103, 1104, 1090, 1032, 1083, 1076, 1063, 1062, 1075, 1067, 1004, 1006, 1091, 108
453530280721, 453530280723, 459801290511, 459801290514, 459801729882, 00884838066854, 00884838086425, 00884838118393
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.