Events

Retiro De Equipo (Recall) de Device Recall BV Pulsera

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Medical Systems North America Co. Phillips.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    39392
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0059-2008
  • Fecha de inicio del evento
    2007-08-23
  • Fecha de publicación del evento
    2007-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55372
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Fluoroscopic Image-Intensified System - Product Code JAA
  • Causa
    System shut down -- unexpected shut down during use of the optional remote control.
  • Acción
    On 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem.

Device

Device Recall BV Pulsera
  • Modelo / Serial
    Serial numbers: 21, 22, 30, 283, 284, 47, 51, 48, 301, 63, 73, 58, 46, 265, 267, 266, 87, 88, 89, 90, 91, 92, 93, 94, 96, 97, 86, 107, 108, 120, 132, 141, 148, 177, 193, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 172, 173, 174, 175, 185, 121, 176, 188, 195, 186, 187, 197, 198, 206, 201, 203, 204, 205, 213, 207, 208, 209, 226, 229, 251, 244, 245, 248, 249, 250, 253, 254, 258, 275, 278, 287, 288, 292, 289, 306, 305, 304, 294, 296, 297, 331, 330, 302, 309, 310, 320, 366, 367, 339, 329, 337, 332, 333, 347, 348, 349, 350, 342, 398, 397, 401, 400, 399, 356, 354, 368, 374, 357, 379, 371, 370, 369, 358, 363, 359, 385, 373, 388, 387, 386, 396, 390, 362, 389, 391, 392, 423, 415, 428, 438, 421, 433, 432, 427, 410, 417, 416, 420, 429, 424, 471, 443, 444, 440, 598, 441, 483, 481, 482, 408, 402, 405, 411, 406, 407, 403, 409, 404, 446, 515, 447, 448, 449, 450, 451, 452, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 465, 466, 469, 470, 472, 475, 476, 477, 509, 528, 506, 505, 523, 534, 504, 537, 507, 502, 500, 499, 501, 473, 474, 518, 521, 520, 642, 519, 641, 526, 525, 536, 533, 557, 543, 468, 552, 553, 571, 555, 556, 577, 559, 620, 558, 579, 570, 599, 575, 635, 633, 634, 580, 625, 624, 597, 636, 589, 674, 639, 638, 590, 637, 640, 631, 630, 593, 594, 595, 632, 1089, 645, 621, 644, 623, 587, 588, 627, 648, 649, 659, 667, 656, 661, 662, 663, 665, 670, 678, 672, 675, 677, 679, 680, 684, 682, 683, 693, 694, 696, 709, 695, 707, 723, 951, 704, 710, 717, 705, 718, 708, 720, 719, 712, 724, 725, 726, 727, 728, 772, 611, 602, 711, 603, 729, 738, 612, 613, 730, 605, 735, 736, 737, 615, 614, 607, 606, 745, 762, 739, 760, 608, 604, 756, 763, 764, 765, 752, 750, 755, 754, 609, 812, 766, 788, 767, 761, 616, 781, 780, 779, 757, 748, 747, 746, 749, 807, 806, 769, 784, 619, 617, 610, 778, 787, 768, 789, 956, 774, 795, 792, 794, 878, 881, 805, 776, 777, 773, 618, 796, 798, 831, 791, 830, 1069, 819, 793, 790, 800, 820, 797, 823, 826, 822, 818, 815, 817, 821, 839, 877, 829, 833, 834, 832, 825, 931, 840, 845, 857, 849, 850, 851, 852, 853, 854, 855, 856, 846, 847, 848, 864, 865, 866, 867, 868, 869, 870, 871, 858, 859, 860, 861, 862, 863, 838, 837, 893, 897, 885, 944, 937, 892, 844, 879, 880, 875, 904, 876, 886, 936, 896, 888, 889, 890, 894, 895, 938, 887, 915, 898, 899, 942, 939, 923, 932, 933, 921, 901, 914, 920, 913, 912, 955, 902, 903, 943, 924, 916, 905, 935, 926, 906, 910, 909, 918, 917, 919, 929, 930, 941, 940, 947, 948, 908, 950, 960, 954, 957, 958, 962, 963, 966, 967, 975, 969, 971, 972, 999, 973, 974, 1038, 976, 1010, 1022, 1021, 977, 978, 979, 983, 1008, 1020, 1023, 1015, 988, 1014, 1018, 1003, 1004, 990, 984, 1009, 996, 1001, 1024, 643, 1039, 985, 1019, 995, 997, 1025, 1026, 998, 1027, 1028, 1002, 986, 987, 1041, 1029, 989, 1078, 1013, 1037, 426, 1017, 1034, 1035, 1042, 1033, 1036, 1070, 1083, 1307, 1062, 1080, 1071, 1072, 1087, 1120, 1082, 1373, 1358, 1094, 1333, 1095, 1363, 1334, 1107, 1359, 1326, 1105, 1106, 1369, 1365, 1375, 1111, 1112, 1376, 1374, 1297, 1304, 1305
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA