Events

Rappel de AD5 table for use with Integris and Integris Allura x-ray systems

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Co. Phillips.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    33873
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0206-06
  • Date de mise en oeuvre de l'événement
    2005-10-12
  • Date de publication de l'événement
    2005-11-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42627
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, X-Ray, Angiographic - Product Code IZI
  • Cause
    Potential for high voltage exposure involving the injector interface connector of patient support tables.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Devices were distributed nationwide to hospitals/medical centers.
  • Description du dispositif
    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
  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA