Events

Device Recall AXIS SPECT Systems & IRIX SPECT Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) Inc 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
    60902
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0988-2012
  • 사례 시작날짜
    2011-11-18
  • 사례 출판 날짜
    2012-02-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106748
  • 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
    System, tomography, computed, emission - Product Code KPS
  • 원인
    Philips was informed that the detector buckets may experience weakness over time. as a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling.
  • 조치
    On 11/15/2011 Philips sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected product, the problem, the hazard involved, and the actions to be taken by users and the Philips. Customers are to place the letter in their User Documentation. Philips service will arrange a time to inspect customers' systems and conduct the appropriate field safety correction. Customers are to contact their local Philips representative if they need further support or information. In the US and Canada, customers can contact Philips Healthcare Customer Care Solutions Center at 1-800-722-9377.

Device

Device Recall AXIS SPECT Systems & IRIX SPECT Systems
  • 모델명 / 제조번호(시리얼번호)
    System Code #, 882130, Serial #, 10, 97, 101, 103, 104, 107-112, 116, 117, 119-121, 123, 125, 127, 130, 132, 133, 135, 138, 142-144, 149-151, 153-158, 162-164, 166, 169-173, 180, 181, 185, 186, 189, 193-204, 214, 215, 218, 219, 221-223, 227, 229-231, 233-237, 240, 242, 244-246, 249-251, 260-262, 264, 267, 272, 273, 275, 277, 280, 281, 283, 285, 291-293, 295, 297-300, 305, 308-310, 312, 316, 319-322, 326-332, 334-336, 338-340, 346, 347, 349, 351, 352, 354, 355, 358-363, 368-370, 374, 377-379, 385, 387, 388, 390-396, 401-407, 411, 412, 416-419, 426-432, 434, 437, 438, 442, 443, 445-447, 449, 452, 457-462, 464, 465, 468, 471, 474, 480-485, 487, 490-493, 495, 496, 499, 502, 503, 505, 508, 509, 511, 513-518, 520, 521, 523, 529, 530, 534, 543-546, 548-560, 562, 563, 569-572, 574-576, 580, 582, 583, 585, 586, 590, 594, 595, 597, 602-607, 611, 612, 618-621, 624-628, 630, 635, 636, 640, 641, 647-650, 654, 656-658, 660-665, 668-673, 675, 679, 681-684, 686, 687, 690-695, 697-699, 701-708, 711-719, 723-729, 733-736, 738, 739, 743-746, 749-753, 755, 756, 759, 760, 762, 764-767, 771-773, 776-778, 780, 781, 786, 789, 790-795, 797, 799, 801, 803-806, 808, 809, 811-814, 818, 820-822, 825-827, 831-834, 836, 837, 839, 840, 841, 843-845, 848, 849, 851-855, 857, 858, 860-862, 865-869, 872-874, 876-881, 884-886, 889, 893, 894, 900-903, 907-922, 924, 927-930, 932, 934, 938-941, 943, 944, 946-948, 951, 953, 954, 958-963, 965-967, 970, 972-980, 982, 983, 985, 986, 991-994, 996-1000, 1003-1008, 1010-1013, 1016, 1017, 1019, 1022, 1023, 2007, 2008, 211037, 2008-0068, 555A, & 778A. System Code #882140, Serial # 102, 134, 141, 146, 147, 159, 160, 161, 167, 175, 176, 190, 209, 210, 216, 225, 226, 257, 259, 268-270, 274, 289, 290, 302, 304, 314, 315, 318, 323, 333, 341, 343, 344, 348, 350, 364, 366, 381, 386, 409, 414, 420, 421, 423, 436, 441, 455, 463, 469, 472, 473, 488, 489, 497, 498, 501, 531, 532, 536-539, 565, 566, 578, 588, 589, 591, 596, 598-600, 608, 610, 613, 615, 616, 622, 631, 632, 634, 637, 653, 666, 674, 676-678, 685, 689, 700, 709, 710, 731, 732, 741, 742, 748, 757, 763, 768, 774, 785, 802, 810, 816, 819, 824, 828, 829, 830, 838, 846, 856, 863, 864, 870, 871, 875, 884, 891, 892, 898, 904, 905, 931, 933, 936, 942, 945, 949, 950, 952, 955-957, 964, 968, 981, 989, 990, 995, 1001, 1002, 1009, 1015, 1018, & 1021. System Code #882130/40, Serial #184, 730, 122, 136, 254, 255, 284, 614, 696, 874, 906, & 984. System Code #882140/882130, Serial #113, 148, 152, 178, 179, 187, 188, 217, 238, 243, 247, 248, 278, 288, 345, 367, 371, 373, 380, 384, 389, 397, 397, 399, 408, 413, 415, 435, 439, 439, 440, 453, 477-479, 486, 504, 512, 525, 526, 528, 533, 535, 540, 547, 564, 567, 568, 577, 579, 581, 638, 639, 644, 645, 651, 652, 659, 667, 680, 747, 758, 815, 850, 859, 882, 883, 890, 896, 897, 899, 925, & 969.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PRO, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and the territory of Puerto Rico; and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Egypt, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, & United Kingdom.
  • 제품 설명
    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. || Used to do nuclear medicine diagnostic imaging of various body organs.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA