Recalls / —

—#55372

Product

Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)

FDA product code

JAA — System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class 2

Medical specialty

Radiology

Affected lot / code info

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

Why it was recalled

System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2007-08-23

Posted by FDA

2007-11-10

Terminated

2010-09-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #55372. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.