Events

Allura Xper 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Co. Phillips 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    44959
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0329-2008
  • 사례 출판 날짜
    2007-12-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64648
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Angiographic x-ray system - Product Code IZI
  • 원인
    Inaccurate anatomical measurements when using the optional smartmask feature.
  • 조치
    The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.

Device

Allura Xper
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers affected:  17, 21, 22, 39, 44, 48, 49, 52, 54, 60, 81, 83, 93, 107, 111, 118, 121, 122, 135, 141, 144, 145, 153, 159, 160, 163, 165, 166, 167, 168, 170, 175, 176, 178, 179, 183, 184, 186, 187, 190, 191, 195, 196, 202, 203, 207, 211, 212, 213, 214, 220, 222, 225, 230, 231, 232, 234, 239, 246, 248, 249, 250, 251, 252, 254, 255, 262, 263, 265, 269, 270, 272, 277, 278, 283, 285, 286, 287, 289, 294, 301, 302, 303, 304, 306, 308, 310, 314, 315, 318, 321, 326, 327, 332, 337, 340, 341, 343, 347, 361, 362, 366, 369, 376, 379, 384, 387, 388, 389, 396, 404, 423, 425, 426, 435, 439, 445, 458, 467, 468, 469, 470, 471, 472, 479, 490, 494, 498, 504, 512, 514, 515, 518, 520, 521, 523, 528, 532, 534, 535, 543, 545, 553, 554, 559, 560, 579, 582, 586, 587, 588, 591, 592, 593, 595, 596, 599, 601, 602, 604, 606, 609, 611, 612, 615, 616, 618, 622, 623, 625, 626, 627, 628, 632, 634, 637, 638, 641, 642, 647, 649, 651, 654, 655, 658, 661, 663, 664, 667, 668, 670, 671, 672, 673, 674, 675, 676, 677, 678, 679, 680, 681, 683, 685, 686, 689, 691, 692, 694, 700, 701, 702, 705, 706, 707, 709, 716, 718, 722, 723, 730, 731, 737, 738, 741, 742, 744, 746, 750, 751, 752, 753, 754, 759, 765, 766, 770, 771, 773, 774, 775, 776, 777, 778, 779, 780, 781, 782, 785, 786, 788, 789, 790, 796, 797, 800, 804, 806, 808, 810, 813, 816, 821, 822, 823, 825, 826, 827, 828, 829, 830, 840, 841, 842, 843, 844, 845, 847, 848, 849, 850, 851, 852, 853, 857, 860, 861, 862, 863, 878, 882, 882, 886, 888, 892, 893, 894, 895, 896, 903, 904, 905, 906, 907, 908, 910, 911, 912, 913, 914, 919, 920, 921, 923, 924, 927, 929, 930, 933, 934, 939, 942, 943, 953, 959, 960, 961, 962, 966, 968, 970, 971, 972, 976, 984, 991, 992, 993, 994, 1007, 1009, 1015, 1032, 1038, 1044, 1045, 1046, 1056, 1075, 1076, 1081, 1085, 1090, 1092, 1093, 1095, 1096, 1098, 1103, 1104, 1105, 1107, 1108, 1114, 1115, 1116, 1118, 1119, 1124, 1126, 1127, 1128, 1132, 1138, 1139, 1140, 1141, 1145, 1147, 1150, 1153, 1161, 1166, 1167, 1168, 1169, 1170, 1174, 1176, 1177, 1178, 1179, 1183, 1187, 1188, 1189, 1190, 1195, 1196, 1201, 1202, 1205, 1206, 1207, 1209, 1211, 1221, 1223, 1227, 1228, 1229, 1235, 1236, 1237, 1240, 1241, 1242, 1252, 1253, 1256, 1258, 1259, 1267, 1268, 1269, 1273, 1274, 1276, 1277, 1279, 1291, 1293, 1294, 1297, 1298, 1300, 1302, 1318, 1321, 1326, 1331, 1338, 1364, 1374, 18165, 43041, 43048, 43051, 43057, 43068, 43070, 43076, 43080, 43081, 43090, 43093, 1674122, 521, 9A, and CG22N41.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

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