Devices

Device Recall INTEGRIS H5000

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • 제품 설명
    INTEGRIS H5000; Model Number: 72246 || The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions
  • Manufacturer
    Philips Electronics North America Corporation
  • 1 Event

제조사

Philips Electronics North America Corporation
  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

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Device Recall Integris H5000F
  • 모델명 / 제조번호(시리얼번호)
    FCO # 72200108 - 1st phase, FCO#72200137 or 72200140 or 72200138 or 72200141 Equipment #'s 100865, 101952, 102564, 102730, 102923, 103275, 103289, 103525, 103696, 103729, 103751, 103875, 103927, 104060, 104106, 104139, 104512, 104536, 104668, 104859, 104927, 105073, 105100, 105137, 105139, 105153, 105156, 105304, 105343, 105386, 105409, 105411, 105582, 105583, 105631, 105684, 105742, 105866, 105908, 105917, 105950, 105951, 105952, 105953, 105961, 500004, 500041, 500052, 504344, 504636, 504638, 504646, 504769, 504776, 504795, 504871, 504904, 504908, 504920, 504977, 504988, 505008, 505017, 505064, 505111, 505135, 505250, 505252, 505270, 505271, 505363, 505421, 505424, 505453, 505520, 505546, 505650, 505680, 505706, 505803, 505804, 505807, 505886, 506009, 506048, 506060, 506121, 506222, 506225, 506369, 506462, 506469, 506541, 506693, 519179, 519199, 519212, 519536, 519673, 519676, 519767, 519868, 519874, 520147, 520189, 520517, 520526, 520840, 521224, 521310, 521313, 521562, 521918, 522224, 530464, 530466, 530655, 530656, 530658, 530668, 532148, 532172, 532234, 532653, 533394, 533541, 533567, 534041, 534155, 534159, 534252, 534627, 534879, 535012, 535091, 535348, 535387, 535777, 537731, 538537, 539507, 540468, 542459, 547283, 555055, and 44536044.  Additional Eqiupment #s for Phase 2 - 10104, 10166, 10277, 10288, 10313, 10325, 10390, 10391, 10403, 10414, 10430, 10431, 10439, 10442, 10454, 10463, 10464, 10465, 10478, 10482, 10495, 13043, 13044, 13093, 13106, 13108, 13113, 13114, 13117, 13230, 13240, 13242, 13259, 13289, 13296, 13530, 13595, 13627, 13631, 13683, 13685, 13688, 13719, 13720, 13731, 13734, 13743, 13756, 13863, 13883, 13890, 13891, 13915, 13941, 13953, 13980, 13990, 13994, 14068, 14168, 17488, 17497, 17504, 17596, 17598, 17599, 25973, 26069, 26072, 26073, 26076, 26109, 26118, 26137, 26158, 26159, 26179, 26217, 26264, 26286, 26288, 26289, 26293, 26295, 35411, 35427, 35436, 35447, 35463, 35505, 37923, 37964, 37970, 37988, 38110, 38181, 38182, 38199, 38201, 38203, 38204, 38205, 38261, 38276, 38290, 38298, 38336, 38352, 38355, 38359, 38373, 38385, 38386, 38387, 38389, 38425, 38437, 38531, 38533, 38554, 38592, 38637, 38642, 38681, 38702, 38703, 38704, 38705, 38718, 38719, 38728, 38733, 38754, 38788, 38789, 38795, 38903, 38916, 38918, 38919, 38926, 38932, 38934, 38935, 38937, 38948, 38949, 38964, 38986, 40389, 40390, 40938, 41017, 41018, 41019, 41021, 41026, 41027, 41079, 41103, 41104, 41109, 41117, 41128, 41137, 41141, 41142, 41145, 41151, 41152, 41153, 41154, 41163, 41164, 41221, 41222, 41224, 41242, 41266, 41267, 41269, 41273, 41328, 41329, 41330, 41335, 41336, 41341, 41405, 41406, 41409, 41425, 41430, 41478, 41479, 41480, 44609, 44712, 44752, 44763, 44774, 44779, 44784, 44825, 44842, 44857, 44860, 44966, 44973, 44978, 45000, 45026, 45045, 45047, 45051, 45058, 45059, 45060, 45072, 45104, 47047, 47110, 47138, 47139, 47190, 50222, 50224, 50305, 50306, 50310, 50311, 50312, 50332, 50335, 50339, 50345, 50371, 50373, 50374, 50389, 50405, 50433, 52451, 52464, 52466, 52476, 52477, 52479, 52480, 52482, 52485, 59366, 59501, 59520, 59548, 59551, 59552, 59610, 59611, 59659, 59698, 59699, 59703, 59709, 59710, 62493, 62524, 62528, 62544, 62557, 62627, 62638, 62639, 62668, 62670, 62770, 62785, 62787, 62804, 62805, 62833, 62834, 62835, 62871, 62892, 62921, 62940, 62942, 62948, 62951, 62969, 62975, 62976, 62999, 68154, 68156, 68168, 68211, 68214, 68231, 68254, 74080, 76214, 76219, 76324, 76325, 76327, 76328, 76343, 76360, 76380, 76397, 76398, 76411, 76445, 76455, 76459, 76462, 76463, 76465, 76471, 76484, 76486, 76499, 76500, 76505, 76510, 76514, 76521, 76522, 76527, 76528, 76545, 76546, 76555, 76557, 76558, 76559, 76574, 76576, 76577, 76817, 76830, 76831, 76832, 76870, 76872, 76873, 76883, 76884, 76885, 76886, 76895, 76933, 76962, 76987, 76995, 80305, 80310, 80315, 80323, 80325, 80330, 82514, 82517, 82520, 82523, 82526, 82539, 82542, 82543, 82575, 82576, 82577, 82591, 82592, 82593, 82612, 82615, 82633, 82635, 82637, 82639, 82640, 82642, 82643, 82661, 82664, 82665, 82676, 82691, 82692, 82696, 82699, 82706, 82711, 82719, 82814, 82815, 82822, 82824, 82825, 82909, 82915, 82916, 82917, 82950, 83016, 83019, 83024, 83026, 83028, 83040, 83042, 83054, 83081, 83309, 83310, 83313, 83322, 83324, 83326, 83375, 83399, 83605, 83607, 83632, 83659, 83663, 83664, 83665, 83667, 83670, 83807, 83821, 83822, 83833, 83838, 83842, 83855, 83861, 83862, 83882, 83903, 83904, 83924, 83926, 83949, 83994, 83996, 84378, 84430, 84431, 84436, 84443, 84445, 84447, 84466, 84467, 84481, 84482, 84713, 84714, 84716, 84790, 84791, 84823, 84826, 84828, 84829, 84838, 84843, 84998, 85004, 85008, 85010, 85011, 85014, 85015, 85054, 85057, 85058, 85087, 85092, 85096, 85106, 85107, 85129, 85131, 85133, 85135, 85169, 85179, 85195, 85197, 85409, 85415, 85416, 85447, 85488, 85498, 85499, 85501, 85503, 85633, 85635, 85637, 85638, 85639, 85640, 85641, 85643, 85676, 85678, 85689, 86057, 86063, 86088, 86126, 86129, 86135, 86145, 86149, 86169, 86170, 86171, 86172, 86183, 86189, 86252, 86253, 86289, 86295, 86296, 86341, 86367, 86420, 86421, 86422, 86424, 86427, 86429, 86431, 86433, 86437, 86488, 86495, 86502, 86505, 86506, 86537, 86539, 86540, 86561, 86571, 86576, 86577, 86578, 86580, 86581, 86598, 86603, 86934, 86935, 86953, 86972, 86981, 86982, 86990, 86991, 86993, 86994, 87004, 87023, 87024, 87055, 87069, 87084, 87179, 87187, 87300, 87315, 87316, 87319, 87324, 87334, 87337, 87364, 87366, 87528, 87530, 87532, 87603, 91650, 100195, 100262, 100319, 100327, 100432, 100450, 100477, 100496, 100504, 100519, 100522, 100607, 100610, 100630, 100631, 100656, 100685, 100697, 100744, 100823, 100839, 100840, 100841, 100861, 100862, 100863, 100864, 100869, 100875, 100881, 100949, 100950, 100959, 100961, 101000, 101006, 101037, 101040, 101077, 101078, 101135, 101136, 101160, 101208, 101216, 101238, 101239, 101564, 101565, 101567, 101571, 101575, 101577, 101582, 101583, 101593, 101612, 101613, 101615, 101617, 101618, 101928, 101938, 101941, 101945, 101971, 101974, 102032, 102039, 102098, 102158, 102162, 102180, 102193, 102243, 102248, 102334, 102348, 102487, 102521, 102555, 102558, 102572, 102575, 102589, 102631, 102635, 102650, 102661, 102664, 102673, 102677, 102723, 102778, 102785, 102793, 102810, 102817, 102823, 102855, 102856, 102868, 102871, 102872, 102936, 102945, 103005, 103063, 103132, 103133, 103150, 103169, 103212, 103213, 103237, 103240, 103241, 103266, 103270, 103290, 103327, 103336, 103371, 103446, 103447, 103448, 103456, 103481, 103512, 103519, 103520, 103535, 103557, 103587, 103594, 103599, 103650, 103656, 103721, 103746, 103763, 103776, 103793, 103812, 103819, 103829, 103830, 103831, 103860, 103879, 103891, 103900, 103926, 103929, 103991, 104033, 104062, 104076, 104169, 104170, 104177, 104187, 104383, 104384, 104385, 104402, 104410, 104413, 104414, 104418, 104423, 104440, 104441, 104513, 104539, 104541, 104580, 104581, 104627, 104753, 104799, 104865, 104884, 104885, 104943, 104974, 104976, 105098, 105299, 105308, 105309, 105389, 105404, 105422, 105514, 105703, 250042, 250046, 250298, 250299, 250338, 250454, 250477, 250550, 504912, 505249, 505567, 519846, 522511, 532078, 532212, 537613, 543761, 557744, 557746, 557772, 557778, 557780, 557795, 557802, 557834, 557840, 557842, 557864, 557866, 557890, 557907, 557926, 557934, 557937, 557939, 557946, 557958, 557962, 557974, 557975, 557976, 557984, 557986, 557997, 558000, 558005, 558021, 558029, 558030, 558032, 558036, 558037, 558070, 558121, 558122, 558145, 558149, 558167, 558168, 558169, 558178, 558182, 558187, 558261, 558265, 558268, 558271, 558278, 558286, 558299, 558323, 558350, 558378, 558383, 43568695, 49788949, 49788952, 49788982, 49789163, 49789164, 49794485, 49794687,and 49794702.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Integris H5000F
  • Manufacturer
    Philips Medical Systems North America Co. Phillips