Devices

Integris XPER FD10 F/C

  • 모델명 / 제조번호(시리얼번호)
    Devices are identified with Site Numbers: 41416358, 554019, 43067304, 555206, 550172, 42393465, 554791, 554768, 553234, 41446290, 556783, 41903960, 554550, 544051, 544048, 556311, 41443882, 38377, 554631, 14147, 41445645, 548067, 41444662, 41446080, 41446144, 557512, 553925, 41443581, 41455906, 552586, 41446807, 554427, 556708, 105686, 104497, 104950, 532446, 104953, 530653, 531926, 533397, 504747, 543989, 534478, 535400, 536379, 537065, 520793, 103281, 556053, 41455894, 554804, 557385, 41445235, 41445816, 530667, 530393, 530666, 534731, 532800, 532799, 535416, 531942, 533762, 535667, 535415, 536138, 534634, 536721, 533283, 533282, 533278, 534638, 537698, 536966, 538744, 534678, 538486, 538485, 538476, 537630, 538368, 540016, 539107, 538903, 540841, 540234, 540301, 537745, 540488, 539595, 540269, 103283, 542113, 542117, 539455, 540070, 539641, 540235, 541822, 535769, 547321, 541409, 541592, 541029, 541026, 534941, 547660, 540386, 539480, 543194, 543209, 537855, 538084, 534928, 541597, 540311, 543702, 543198, 543433, 533289, 543108, 544145, 535212, 543873, 538432, 544506, 541588, 544572, 543829, 532226, 543610, 541667, 545037, 545069, 545357, 545365, 545296, 545443, 544990, 544992, 545052, 544610, 545966, 546012, 537588, 541510, 544637, 103147, 546934, 543999, 544122, 520275, 547279, 543988, 546572, 547165, 547908, 548147, 537937, 537935, 537589, 548038, 547878, 549451, 545942, 548525, 545395, 548603, 548645, 547159, 548966, 549013, 539516, 532235, 545023, 547600, 547406, 539224, 549400, 547965, 547749, 549792, 551379, 538416, 550255, 547761, 547763, 547762, 551633, 544600, 541080, 532611, 80327, 554896, 555605, 554499, 546560, 546561,  550360, 553137, 41455880, 550124, 41445229, 41455932, and 556773.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). || Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips
  • 1 Event

제조사

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

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Device Recall Integris XPER FD10 F/C
  • 모델명 / 제조번호(시리얼번호)
    FCO 72200111, 72200119, and 72200142 for the 1st phase 72200132 for the 2nd phase Equipment #'s 14147, 38377, 80327, 103147, 104497, 104950, 104953, 105686, 504747, 505254, 505860, 520275, 520793, 522138, 530393, 530667, 531926, 531942, 532226, 532235, 532446, 532611, 532799, 532800, 533278, 533282, 533283, 533289, 533476, 533762, 534634, 534638, 534678, 534731, 534928, 534941, 535212, 535400, 535415, 535416, 535667, 535769, 536138, 536379, 536721, 536966, 537588, 537589, 537630, 537698, 537745, 537855, 537935, 537937, 538084, 538368, 538416, 538432, 538476, 538485, 538486, 538744, 538903, 539107, 539224, 539455, 539480, 539516, 539595, 539641, 540016, 540070, 540234, 540235, 540269, 540301, 540311, 540386, 540488, 540841, 541026, 541029, 541080, 541409, 541510, 541588, 541592, 541597, 541657, 541667, 541822, 542109, 542113, 542117, 543108, 543194, 543198, 543209, 543433, 543610, 543702, 543829, 543873, 543988, 543999, 544048, 544051, 544122, 544145, 544506, 544572, 544600, 544610, 544637, 544990, 544992, 545023, 545037, 545052, 545069, 545296, 545357, 545365, 545395, 545443, 545942, 545966, 546012, 546560, 546561, 546572, 546934, 547159, 547165, 547279, 547321, 547406, 547600, 547660, 547749, 547761, 547762, 547763, 547878, 547908, 547965, 548038, 548067, 548147, 548525, 548603, 548645, 548966, 549013, 549400, 549451, 549738, 549792, 550124, 550172, 550255, 550360, 551379, 551633, 552470, 552585, 552586, 553137, 553234, 553351, 553352, 553430, 553858, 553925, 553986, 554019, 554427, 554431, 554442, 554444, 554499, 554550, 554556, 554631, 554745, 554768, 554791, 554804, 554896, 555206, 555605, 556053, 556311, 556708, 556773, 556783, 557385, 557512, 41416358, 41443581, 41443882, 41444662, 41445229, 41445235, 41445645, 41445816, 41446080, 41446144, 41446290, 41446807, 41455880, 41455894, 41455906, 41455932, 41903960, 42393465, 43067304, 43151051, 43719245, 44048177, and 44604746.  Additional Equipment #s from Phase 2 - 10105, 10483, 13107, 13292, 13914, 13954, 13997, 26218, 38356, 38378, 52463, 62891, 76489, 76867, 76955, 76986, 80322, 84468, 85137, 85190, 85692, 86008, 101949, 102809, 103445, 103554, 103901, 104038, 104201, 104335, 104416, 104910, 104978, 250083, 250146, 250149, 250201, 250674, 505968, 543408, 553964, 553981, 558148, 558198, 41444419, 41444609, 41444680, 41444728, 41445001, 41445032, 41445250, 41445270, 41445303, 41445344, 41445744, 41445766, 41446212, 41446216, 41612034, 41622975, 41793888, 41795224, 42057739, 42067846, 42371287, 42393532, 42508767, 42639096, 42799507, 42799589, 42799745, 42816302, 43179280, 43209360, 43259235, 43270340, 43305020, 43709318, 43721227, 43902667, 43931289, 44193720, 44450326, 44743568, and 45321194.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Integris XPER FD10 F/C
  • Manufacturer
    Philips Medical Systems North America Co. Phillips