Events

AD5 table for use with Integris and Integris Allura x-ray systems 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
    33873
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0206-06
  • 사례 시작날짜
    2005-10-12
  • 사례 출판 날짜
    2005-11-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42627
  • 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, X-Ray, Angiographic - Product Code IZI
  • 원인
    Potential for high voltage exposure involving the injector interface connector of patient support tables.
  • 조치
    On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

Device

AD5 table for use with Integris and Integris Allura x-ray systems
  • 모델명 / 제조번호(시리얼번호)
    Site numbers for all tables/units: X0375, X0656, X0621, X0655, X1410, 104414, X0371, X1310, X0373, X0632, X1691, 104413, X0053, X0381, X1408, 105511, 104974, 13953, 104529, 104536, 504494, 76839, 504795, 105491, 103900, 105137, 105703, 105404, 103987, 103231, 104513, 103240, 532172, 100713, 104512, 103237, 504977, 103613, 103481, 506222, 103860, 103584, 504776, 533567, 104402, 530653, 85094, 103287, 103382, 103710, 103594, 103448, 104581, 105731, 105736, 103712, 105514, 105773, 103746, 104580, 100504, 85014, 100643, 506119, 103776, 530654, 530655, 104385, 103281, 102856, 104386, 76556, 103133, 104177, 86296, 103709, 104388, 103751, 520275, 504742, 105308, 520517, 105299, 103714, 103891, 506225, 505421, 105733, 505424, 105305, 13534, 538537, 103379, 102631, 504988, 535761, 104943, 103257, 104927, 104926, 86561, 102826, 102580, 76817, 102009, 102983, 76815, 102872, 103032, 105489, 504674, 505067, 505017, 104539, 102710, 104415, X0105, 102811, X0628, 105243, 533288, X0393, 105339, 104424, 104430, 104194, 104420, X1262, 104975, 103150, 103823, 105254, 86008, 104909, 102923, 506462, 105409, 104953, 102974, 104959, 104950, 103148, 100913, 41281, 105658, 104077, 101485, 103722, 102723, 103729, 104497, 105654, 504779, 100708, 41273, 522136, 84430, 104076, 103512, 100744, 84431, 104668, 505703, 103372, 103275, 104198, 104516, 103309, 102502, 104096, 104797, 104511, 104187, 535348, 535345, 100631, 105411, 103721, 104060, 105631, 534627, 102103, 504904, 104062, 103793, 104865, 538172, 100866, 103063, 105399, 84444, 105304, 84466, 84468, 101941, 103290, 100863, 103289, 103169, 103170, 102817, 103371, 104068, 104976, X1636, 504912, 250531, 104427, 250046, 521325, 250084, 250454, X1284, X1282, 103456, X1694, 250042, 102675, 105294, 103003, 103004, 103446, 104418, X0894, 504528, X0098, X0627, 103070, 104412, 102776, 103494, 102945, 100519, 505111, 102953, 504777, 103335, 101582, 519179, 103630, 505008, 101971, 104631, 103599, 104440, 101577, 59520, 103829, 103828, 105386, 103183, 104106, 104195, 534156, 105742, 105951, 103336, 105952, 105953, 100450, 101139, 102493, 101565, 100587, 105389, 101576, 103819, 102487, 101864, 104139, 102793, 104885, 104020, 104884, 103921, 104107, 103193, 102944, 102785, 104628, 100319, 104859, 103238, 41152, 103743, 104111, 102936, 86501, 87359, 102937, 103991, 105153, 103201, 104627, 59491, 105156, 101965, 105950, 102575, 101136, 105100, 101974, 104441, 102589, 250005, 505546, 250299, 250298, 104426, 103879, 504530, 104630, 103696, 103132, 105737, 504788, 104933, 104148, 105770, 103356, 103021, 103901, 103381, 505530, 103355, 105583, 105343, 103777, 102555, 102521, 521149, 103650, 102248, 100477, 505807, 103557, 105581, 103656, 102334, 104145, 101000, 103929, 519196, 105184, 101613, 104057, 103518, 103241, 103519, 103520, 41137, 104463, 103535, 519197, 105139, 103248, 105582, 102563, 102564, 104169, 104170, 102730, 103581, 41080, 103526, 103029, 103525, 103270, 103266, 104541, 537593, 103246, 105585, 103927, 103926, 104056, 100810, 101433, 13868, 504733, 504769, 100959, 104337, 506778, 104335, 105098, 103875, 504903, 102635, 505271, 105309, 103587, 537731, X1164, X0179, X0043, X0079, X0683, 533290, X0093, 505064, 102612, 102868, X0040, X1036, X0134, X1716, X0146, X1794, X1246, X1492, X0767, X1228, 505453, 84721, 14044, 13685, 100657, 13230, 13720, 13629, 13615, 13628, 13644, 13710, 13890, 86992, 13954, 102632, 85013, 13756, 13683, 13910, 530660, 13046, 13044, 13992, 13993, 104341, 13699, 13113, 13734, 102179, 102161, 102180, 101077, 14021, 84714, 13631, 102098, 13863, 85096, 6820, 506693, 6821, 6837, 6833, 10391, 76918, 10105, 532241, 6788, 86953, 532240, 10288, 76880, 6944, 6949, 6876, 6777, 76872, 85004, 86975, 100696, 6814, 76882, 6875, 6778, 6869, 76931, 6962, 102037, 76933, 102038, 76932, 80325, 41355, 86088, 41374, 41406, 100714, 41328, 41269, 101589, 41268, 86135, 35488, 532218, 86057, 83399, 100607, 530396, 35505, 41176, 86087, 35489, 84843, 38925, 521918, 41191, 87528, 100606, 82692, 41329, 52451, 38926, 505270, 35436, 41335, 76411, 76325, 41272, 84447, 84791, 10329, 100521, 76324, 82945, 102418, 101873, 103763, 100961, 532148, 76335, 76527, 82917, 38986, 10104, 83855, 10403, 76460, 62636, 17470, 76462, 62639, 532234, 519673, 62638, 76214, 17547, 17578, 76595, 76463, 62940, 62772, 84713, 519536, 535387, 76328, 104403, 76445, 17596, 76343, 76327, 76387, 76514, 17504, 100869, 10464, 519199, 76459, 102746, 10166, 76500, 102863, 84829, 84828, 520526, 76380, 86272, 100645, 86935, 17472, 86914, 86934, 521525, 10482, 102348, 76580, 101239, 85057, 504646, 85090, 10463, 506121, 10277, 86981, 10454, 85095, 85087, 13106, 17628, 101945, 13108, 13109, 10465, 17529, 76574, 76575, 76454, 17497, 82915, 76576, 76577, 76594, 17598, 76528, 76512, 76511, 10495, 17519, 17474, 76505, 86289, 17612, 76360, 17475, 102855, 76395, 103283, 76471, 103957, 84715, 530658, 103380, 530656, 17453, 84716, 103282, 76557, 17626, 76198, 530668, 76504, 505135, 76389, 17633, 76503, 76546, 76342, 17627, 82909, 76545, 13259, 76560, 534252, 86971, 76559, 100788, 76520, 530464, 76398, 76558, 76397, 505650, 76346, 76555, 86972, 102000, 85041, 101609, 102001, 85016, 82950, 533541, 10478, 87603, 76490, 85092, 59659, 76489, 85055, 13599, 76378, 13990, 86295, 82916, 10430, 17291, 13296, 14026, 14029, 17488, 84826, 76465, 520840, 17528, 17458, 17514, 76522, 76455, 86252, 103005, 76497, 17492, 10325, 17599, 76572, 76510, 17502, 534879, 100470, 76521, 506069, 14168, 14145, 101078, 13688, 13627, 102158, 13689, 13634, 10431, 13577, 13530, 13732, 13043, 13937, 102166, 13117, 10390, 10440, 100823, 13941, 13719, 13980, 10439, 13292, 62648, 505068, 83841, 86583, 86578, 534756, 86584, 62559, 87300, 62871, 62892, 82709, 100948, 62519, 83833, 522456, 82528, 6911, 13290, 76917, 76941, 6818, 13093, 13289, 13294, 6967, 76870, 85008, 519118, 102842, 84734, 101610, 76867, 86290, 10414, 6957, 6867, 6996, 102823, 6995, 13670, 14101, 504868, 102869, 10455, 10441, 13575, 86993, 13605, 13617, 86991, 10462, 13107, 86989, 85010, 102160, 13592, 85011, 102572, 10313, 13664, 86982, 13240, 85058, 13997, 13596, 13595, 102162, 102908, X0187, 250334, X1035, X1327, X1222, 102707, X1566, 531799, X1269, X1313, X1724, X1733, X1732, 104410, 537175, X1646, X1528, X1546, X1557, 534131, 103211, X0712, X1235, X0436, X1558, X1718, X1717, 102871, X1324, X1547, X1476, 250338, X0078, 86144, 37964, 82637, 38017, 38204, 87530, 38028, 82638, 520949, 37894, 87179, 38199, 83323, 37923, 84443, 38146, 100701, 82635, 82661, 82639, 38080, 100704, 38205, 82640, 82636, 38062, 100585, 41405, 86066, 41411, 82696, 41341, 80323, 41163, 41336, 41154, 41267, 31023, 521313, 100613, 52488, 84436, 41340, 41266, 84852, 505886, 80320, 41242, 86061, 41178, 41151, 84445, 35448, 35441, 80330, 519981, 101606, 41164, 103147, 82676, 80322, 52465, 101607, 100262, 41409, 52466, 41150, 41155, 41207, 82642, 82633, 41385, 52463, 37924, 37970, 84481, 100641, 86063, 84378, 38203, 37959, 103213, 38206, 103212, X0609, 86189, 35463, X0051, X1268, X0626, X1699, 83313, X1168, X1738, 52464, X0610, 504636, 80315, 80310, 101040, X0202, 86129, 504638, X1736, 102629, 41153, 35473, 83310, 35434, 80305, 35427, 82691, 80327, 52470, 41221, 35485, 41294, 84487, 82699, 41293, 83324, 35593, 83322, 41224, 41222, 102193, 84827, 52477, 41330, 520582, 82664, 100783, 52476, 86136, 52485, 52480, 86126, 35447, 84489, 52482, 86022, 101309, 86149, 52479, 83375, X1185, X0041, X0913, 102673, X0893, 86172, X0044, X1498, X0036, X1685, X1496, X0042, X1686, X1237, 37988, 38181, 38182, X1584, 38201, 38186, 38385, 100865, 26295, 26289, 26063, 26288, 25974, 25993, 84467, 38387, 26158, 26293, 26064, 82665, 26062, 83326, 101465, 100630, 26109, 25979, 26264, 38386, 26286, 38416, 504655, 26204, 26217, 86065, 82608, 26048, 82615, 26179, 84821, 505706, 101073, 38377, 82612, 83311, 26218, 38406, 86170, 101110, 38376, 86169, 83327, 82609, 86145, 38378, 102243, 82643, 100611, 86171, 86196, 26095, 26073, 100864, 38425, 26069, 504908, 100862, 26108, 38426, 26137, 25964, 38389, 519730, 84823, 26268, 100861, 26076, 25998, 26072, 103034, X1146, 522224, X1158, X1159, 250333, 102809, 91650, X1342, X1491, X1064, X1223, X1065, X1493, X0384, 519676, X1486, 104384, 104383, X1186, 102810, X1315, X1637, 102664, X1665, X0434, X0069, X1527, X1358, X0902, X0889, 531926, X0377, 506655, X0066, 102870, X1389, 102715, X0063, 103002, X0939, 104382, 505680, X1341, X1227, X1224, 250073, X0103, X1525, X1499, X1474, 103420, X0017, 103447, X1695, X0969, X0975, X1232, X1596, X0886, X1066, X1339, 103214, 87316, 100496, 86435, 38704, 62999, 62528, 62544, 62787, 62424, 38705, 38703, 86537, 86433, 83605, 86488, 83670, 38789, 62606, 102874, 62521, 534786, 82591, 82711, 38702, 62975, 62805, 62668, 38261, 62948, 62524, 62942, 38790, 62833, 38792, 83632, 101583, 59400, 87339, 103182, 38573, 83834, 86421, 59434, 59368, 83862, 101966, 83861, 83842, 59501, 38554, 83875, 41480, 38788, 41455, 41478, 41475, 104565, 38533, 38532, 83665, 59391, 38531, 101238, 59710, 520701, 82589, 86506, 101564, 83664, 520688, 82542, 535777, 59421, 86450, 38642, 506509, 85639, 83663, 87334, 59422, 38681, 86502, 62655, 38755, 532152, 62786, 62653, 59418, 59373, 83840, 62968, 62891, 62765, 62637, 62920, 38795, 62921, 62773, 62803, 521310, 62669, 85638, 85498, 85497, 62651, 62967, 62649, 102790, 102714, 520189, 62798, 535775, 38754, 59396, 59390, 83863, 38757, 86422, 101575, 86572, 82523, 76953, 102094, 85488, 86536, 86542, 84998, 83667, 86603, 85409, 38964, 38928, 41479, 68255, 68254, 62531, 62493, 519868, 100328, 82575, 62460, 62483, 505380, 62969, 86581, 82514, 86424, 82520, 62459, 82719, 102032, 82706, 86580, 82521, 38934, 38941, 38868, 103144, 68157, 86494, 86427, 76986, 87317, 87318, 41423, 82572, 41460, 38879, 38882, 41461, 105908, 76955, 102650, 38949, 38935, 38906, 506469, 82537, 41424, 82576, 41430, 38903, 68231, 38905, 38907, 520756, 76995, 67587, 531939, 100841, 41458, 41425, 38904, 534155, 506369, 82577, 102778, 38862, 38937, 76992, 68156, 38916, 85692, 68214, 38918, 82593, 102096, 87366, 506009, 85678, 76999, 68168, 101216, 76987, 38932, 519874, 85501, 519212, 86429, 74080, 505363, 86575, 86431, 59552, 83821, 83838, 82592, 82526, 59709, 86577, 85676, 85633, 100327, 82517, 85416, 85635, 505356, 59703, 101938, 100881, 59557, 85415, 85634, 100875, 105684, 59675, 38637, 100685, 87337, 59699, 59698, 59551, 59610, 59548, 534159, 83807, 59611, 100839, 83882, 82539, 59527, 87319, 74053, 504871, 500004, 100610, 86598, 86576, 101973, 101135, 38592, 100950, 100840, 85643, 101949, 100949, 82522, 83659, 101566, 86495, 101567, 85689, 85640, 101952, 62998, 87324, 62804, 62770, 62627, 86539, 62557, 38718, 62435, 105961, 62628, 62834, 521562, 100658, 85641, 38733, 38728, 86538, 62835, 38719, 86456, 62436, 86540, 62977, X1687, 506060, 250581, 250300, 102676, 102677, X1643, 87315, 62941, 62508, 86437, 506048, 86419, 62779, 62776, 62671, 83823, 87364, 62792, 62775, 62774, 86415, 62625, 86434, 62976, 62806, 62670, 100316, 6946, 76885, 76884, 76883, 6785, 519767, 101205, 103022, 76886, 85070, 85018, 100485, 76831, 6783, 86253, 506026, 103255, 76873, 6784, 76832, 537181, 6951, 44877, 44845, 44842, 83996, 45059, 35450, 83024, 86360, 85179, 100432, 50335, 76365, 38948, 44976, 44860, 44850, 44977, 506541, 85107, 45058, 44975, 45066, 45026, 44844, 44978, 50312, 44821, 44763, 44774, 504344, 85133, 44848, 87024, 44825, 50339, 44779, 103015, 44973, 50222, 50311, 50224, 44854, 532383, 50223, 100719, 50388, 45077, 50345, 50197, 50203, 101615, 85129, 85106, 102523, 87004, 101928, 505252, 500041, 101160, 102995, 102083, 44946, 50202, 44768, 505803, 50186, 531649, 44809, 83081, 44767, 50185, 44712, 101430, 50375, 44714, 101208, 87023, 83927, 45045, 44857, 44972, 44971, 82815, 86322, 83054, 82814, 50374, 44740, 47187, 13731, 105073, 101036, 83949, 50433, 50419, 87081, 45060, 44752, 44719, 82822, 45104, 82823, 50332, 50438, 50306, 45047, 50305, 85196, 45048, 45072, 505250, 83904, 100475, 44896, 85169, 87084, 87070, 47185, 85135, 41026, 47139, 41116, 41139, 83926, 41109, 85137, 47141, 47089, 86321.47188, 38339, 41050, 100812, 41027, 85197, 520964, 87068, 87069, 40390, 40389, 102949, 101620, 85195, 83026, 41017, 85131, 533394, 102558, 100656, 85126, 41028, 47138, 38358, 38359, 38276, 41117, 86398, 83040, 40917, 68211, 83019, 38356, 41145, 47127, 86332, 82825, 38352, 41079, 41129, 41104, 40929, 38298, 86341, 47168, 47169, 38373, 86319, 38329, 41103, 83924, 82824, 38290, 41141, 47269, 83028, 83013, 40905, 47106, 47046, 100945, 85130, 41019, 87055, 47140, 41128, 41021, 47110, 100683, 87013, 47042, 83015, 38355, 100811, 41018, 101617, 40938, 105866, 101619, 41115, 41114, 47190, 101037, 83016, 101618, 82812, 101612, 44808, 44784, 50389, 50392, 83994, 44820, 533397, 50371, 44886, 45051, 44969, 50373, 86367, 85128, 101434, 44966, 13716, 13982, 13743, 13590, 13914, 13915, 13242, 85015, 14147, 13589, 105422, 85499, 13883, 85098, 84790, 10442, 13994, 86994, 530466, 13114
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were distributed nationwide to hospitals/medical centers.
  • 제품 설명
    AD5 table for use with Integris and Integris Allura x-ray systems
  • 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