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U.S. Department of Health and Human Services

Class 2 Device Recall BV Pulsera

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  Class 2 Device Recall BV Pulsera see related information
Date Initiated by Firm August 23, 2007
Date Posted November 10, 2007
Recall Status1 Terminated 3 on September 27, 2010
Recall Number Z-0059-2008
Recall Event ID 39392
510(K)Number K919435  
Product Classification Fluoroscopic Image-Intensified System - Product Code JAA
Product Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)
Code Information 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
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
425-487-7602
Manufacturer Reason
for Recall		 System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 596 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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