FDA Home Page | CDRH Home Page | Search | A-Z Index

510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards

New Search Back To Search Results   Medical Device Recalls Class 2 Recall Bucky Diagnost Date Recall Initiated July 23, 0007 Date Posted September 25, 2007 Recall Number Z-0907-2007 Product Philips Bucky DIagnost X-Ray System Code Information 38950, 38951, 38952, 38953, 38979, 38980, 38999, 40092, 40189, 40203, 40263, 40476, 40511, 40623, 40686, 40899, 40920, 40933, 40934, 40939, 40972, 41009, 41036, 41037, 41041, 41042, 41061, 41074, 41081, 41088, 41089, 41090, 41091, 41093, 41097, 41100, 41101, 41106, 41110, 41119, 41126, 41144, 41158, 41168, 41244, 41259, 41260, 41261, 41270, 41283, 41285, 41334, 41353, 41384, 41401, 41408, 41419, 41421, 41434, 41438, 41464, 41469, 41471, 41472, 41473, 43259, 43269, 43342, 43450, 43451, 43522, 43685, 43912, 44006, 44769, 44795, 44796, 44797, 44798, 44799, 44800, 44801, 44831, 44851, 44889, 44949, 44963, 45015, 45027, 45028, 45030, 45031, 45034, 45035, 45040, 45043, 45064, 45093, 46114, 46326, 46413, 46656, 46668, 46845, 46870, 46873, 46876, 46969, 46985, 47061, 47068, 47092, 47099, 47116, 47148, 47150, 47173, 47175, 47176, 47182, 47186, 47267, 49052, 49053, 49087, 49167, 49308, 50232, 50233, 50234, 50237, 50341, 50342, 50343, 50386, 52452, 52453, 52454, 52457, 52458, 52474, 52475, 52490, 58153, 58204, 58227, 58238, 58241, 58257, 58392, 58624, 58733, 58753, 58754, 58767, 58861, 58862, 58867, 58965, 58969, 58970, 58971, 59017, 59033, 59226, 59227, 59244, 59284, 59362, 59402, 59403, 59404, 59405, 59406, 59407, 59449, 59450, 59509, 59517, 59519, 59543, 59550, 59561, 59563, 59570, 59609, 59649, 59664, 59665, 59668, 59669, 61072, 61387, 61423, 61458, 61576, 61968, 62002, 62282, 62296, 62342, 62431, 62468, 62469, 62477, 62499, 62500, 62501, 62553, 62602, 62603, 62604, 62609, 62616, 62617, 62665, 62766, 62769, 62771, 62783, 62883, 62884, 62886, 62890, 62928, 62929, 62935, 62939, 62995, 64085, 64162, 64163, 64208, 64283, 64322, 64360, 64369, 64374, 64411, 64504, 64657, 65170, 67189, 67290, 67447, 67535, 73296, 73340, 73351, 74062, 74063, 74083, 76034, 76077, 76159, 76193, 76194, 76215, 76222, 76336, 76369, 76370, 76392, 76393, 76440, 76457, 76458, 76496, 76524, 76579, 76586, 76803, 76819, 76835, 76836, 76846, 76888, 76889, 76891, 76894, 76905, 76906, 76908, 76920, 76921, 76922, 76926, 76943, 76949, 76969, 76970, 76971, 76981, 76991, 76998, 80316, 80333, 82557, 82558, 82559, 82560, 82568, 82569, 82614, 82629, 82631, 82632, 82647, 82648, 82654, 82658, 82659, 82686, 82705, 82718, 82723, 82732, 82808, 82826, 82828, 82832, 82833, 82835, 82919, 82938, 83008, 83009, 83010, 83011, 83012, 83029, 83037, 83043, 83305, 83331, 83332, 83338, 83341, 83371, 83372, 83390, 83391, 83565, 83566, 83603, 83614, 83619, 83652, 83653, 83699, 83800, 83801, 83866, 83900, 83901, 83908, 83942, 83948, 83960, 83998, 84419, 84439, 84440, 84453, 84454, 84455, 84456, 84457, 84458, 84488, 84497, 84701, 84705, 84723, 84731, 84817, 84818, 84837, 84846, 84847, 84848, 84849, 84891, 84894, 84929, 84932, 84937, 84943, 84965, 84972, 85009, 85036, 85053, 85063, 85066, 85069, 85103, 85115, 85118, 85151, 85152, 85162, 85164, 85181, 85193, 85194, 85199, 85439, 85461, 85462, 85463, 85466, 85468, 85627, 85628, 85699, 85860, 86014, 86016, 86073, 86075, 86117, 86119, 86120, 86123, 86141, 86210, 86211, 86212, 86219, 86220, 86225, 86227, 86230, 86231, 86266, 86267, 86268, 86269, 86270, 86279, 86300, 86301, 86302, 86304, 86306, 86307, 86308, 86311, 86312, 86336, 86337, 86338, 86357, 86361, 86369, 86385, 86388, 86392, 86402, 86455, 86472, 86493, 86507, 86544, 86546, 86550, 86602, 86605, 86614, 86615, 86621, 86902, 86904, 86919, 86920, 86921, 86943, 86951, 86963, 86973, 86974, 87003, 87014, 87015, 87025, 87026, 87027, 87028, 87032, 87039, 87049, 87057, 87071, 87073, 87074, 87082, 87141, 87144, 87301, 87303, 87321, 87338, 87602, 87606, 87608, 100039, 100094, 100203, 100244, 100245, 100433, 100437, 100439, 100455, 100490, 100544, 100547, 100569, 100571, 100572, 100573, 100584, 100591, 100602, 100616, 100617, 100634, 100642, 100659, 100678, 100699, 100705, 100772, 100782, 100806, 100814, 100824, 100827, 100830, 100831, 100836, 100853, 100868, 100871, 100872, 100885, 100891, 100995, 100998, 101029, 101068, 101081, 101082, 101189, 101209, 101218, 101315, 101379, 101380, 101405, 101410, 101436, 1Site numbers 4058, 4061, 4068, 4073, 4089, 4157, 4162, 4183, 5078, 5086, 5131, 6089, 6161, 6180, 6182, 6183, 6604, 6639, 10011, 10044, 10057, 10154, 10192, 10201, 10242, 10246, 13035, 13036, 13038, 13039, 13070, 13152, 13943, 14003, 14018, 14115, 14143, 14159, 16066, 16163, 16168, 17621, 17631, 17657, 19028, 19111, 19121, 19183, 19268, 19295, 19548, 25008, 25172, 25299, 25303, 25311, 25331, 25358, 25359, 25697, 25719, 25920, 26025, 26030, 28154, 28157, 28169, 28276, 31114, 31155, 33667, 34053, 34078, 34287, 34452, 35273, 37024, 37114, 37121, 37123, 37141, 37341, 37476, 37950, 38252, 38408, 38542, 38671, 38677, 38678, 38682, 38683, 38798, 38884, 38959, 40133, 40210, 40530, 40543, 40650, 40651, 40660, 40664, 40798, 40833, 40935, 43036, 43044, 43139, 43311, 43340, 43357, 43424, 43607, 43689, 43727, 43789, 43952, 44003, 44033, 44548, 44807, 44867, 46032, 46079, 46093, 46112, 46357, 46369, 46504, 46520, 46540, 46582, 46594, 46595, 46618, 46626, 46656, 46869, 46899, 47172, 49003, 49035, 49049, 49051, 49093, 49192, 49201, 49208, 49222, 49304, 49317, 49333, 49358, 49438, 49655, 50237, 50448, 58113, 58115, 58128, 58129, 58146, 58148, 58192, 58223, 58250, 58338, 58386, 58399, 58539, 58626, 58627, 58658, 58713, 58714, 58715, 58768, 58820, 58821, 58876, 58907, 59250, 61138, 61276, 61483, 61606, 61618, 61719, 61721, 61946, 62345, 62417, 62619, 62930, 62932, 62960, 64141, 64142, 64257, 64347, 64447, 64463, 64467, 64634, 64640, 64644, 67001, 67009, 67021, 67086, 67184, 67211, 67216, 67226, 67247, 67450, 67468, 67558, 67591, 67737, 67980, 68201, 73452, 73741, 73995, 76081, 76110, 76114, 76126, 76526, 82566, 82941, 83206, 83339, 83340, 84465, 84935, 85143, 85495, 85697, 85698, 85699, 86017, 86310, 86382, 86383, 86390, 102458, 102460, 102461, 102899, 103278, 103442, 103534, 104203, 250482, 250501, 250682, 250794, 504462, 506846, 521543, 542076, 542237, 542380, 542458, 542535, 542576, 543134, 543666, 543757, X0178, X0181, X0334, X0336, X0337, X0471, X0769, X1073, X1147, X1148, X1219, X1293, X1296, X1298, X1333, X1377, X1436, X1641, X1650, X1767, X1768 5024, 5175, 6135, 6143, 6181, 6228, 6717, 6740, 6759, 6773, 6786, 6797, 6798, 6810, 6826, 6836, 6843, 6857, 6858, 6859, 6864, 6866, 6873, 6883, 6884, 6885, 6888, 6889, 6893, 6903, 6904, 6920, 6925, 6932, 6936, 6954, 6958, 6959, 6964, 6973, 6974, 6982, 6988, 6989, 6992, 10029, 10033, 10066, 10145, 10417, 10419, 10429, 10434, 10461, 10477, 10481, 10498, 10499, 13012, 13028, 13032, 13034, 13122, 13125, 13131, 13146, 13159, 13175, 13198, 13216, 13224, 13225, 13243, 13244, 13246, 13247, 13248, 13249, 13250, 13251, 13252, 13254, 13256, 13278, 13279, 13295, 13611, 13613, 13632, 13636, 13648, 13649, 13650, 13654, 13655, 13667, 13698, 13706, 13712, 13726, 13728, 13741, 13744, 13869, 13870, 13871, 13872, 13887, 13892, 13893, 13896, 13909, 13912, 13920, 13957, 13973, 13974, 13975, 14076, 14078, 14081, 14176, 16027, 16278, 16294, 16399, 16473, 16552, 16572, 16609, 17166, 17248, 17298, 17494, 17516, 17540, 17567, 17568, 17569, 17570, 17571, 17582, 17588, 17589, 17591, 17634, 17658, 17659, 17660, 17661, 17662, 17671, 17672, 17673, 19050, 19124, 19176, 19304, 19329, 19336, 25007, 25448, 25627, 25628, 25898, 26015, 26023, 26024, 26026, 26028, 26029, 26044, 26045, 26130, 26141, 26153, 26155, 26156, 26205, 26206, 26208, 26209, 26210, 26273, 26274, 26283, 28043, 28077, 28079, 28081, 28105, 28148, 28179, 28243, 31113, 34031, 34348, 34734, 35156, 35482, 35483, 35584, 35585, 35596, 37387, 37582, 37583, 37906, 37949, 37951, 37952, 37955, 37967, 37968, 37978, 37980, 37989, 37999, 38005, 38011, 38012, 38013, 38068, 38082, 38085, 38090, 38092, 38093, 38099, 38100, 38103, 38128, 38129, 38130, 38131, 38132, 38135, 38140, 38148, 38157, 38176, 38193, 38194, 38197, 38251, 38253, 38258, 38259, 38281, 38299, 38300, 38319, 38323, 38350, 38354, 38367, 38368, 38421, 38446, 38606, 38609, 38621, 38622, 38633, 38667, 38684, 38694, 38726, 38741, 38742, 38746, 38747, 38866, 38867, 38875, 38876, 38877, 38878, 38887, 38900, 38927,01437, 101553, 101559, 101592, 101638, 101702, 101703, 101704, 101705, 101882, 101883, 101885, 101933, 101944, 101947, 101980, 101984, 101985, 101986, 101989, 101997, 102010, 102016, 102017, 102020, 102022, 102023, 102026, 102027, 102040, 102080, 102108, 102113, 102122, 102124, 102128, 102129, 102134, 102291, 102355, 102358, 102360, 102421, 102443, 102456, 102470, 102494, 102495, 102496, 102509, 102528, 102529, 102530, 102605, 102618, 102619, 102620, 102621, 102626, 102646, 102648, 102649, 102706, 102712, 102721, 102725, 102726, 102727, 102775, 102779, 102784, 102792, 102891, 102898, 102901, 102902, 102904, 102909, 102910, 102920, 102927, 102981, 102997, 102998, 103001, 103010, 103024, 103025, 103031, 103044, 103048, 103049, 103054, 103067, 103073, 103074, 103102, 103104, 103105, 103114, 103127, 103138, 103155, 103156, 103162, 103194, 103195, 103203, 103206, 103208, 103251, 103259, 103269, 103277, 103288, 103311, 103314, 103332, 103334, 103352, 103358, 103360, 103365, 103369, 103386, 103412, 103413, 103425, 103428, 103429, 103430, 103431, 103432, 103433, 103440, 103441, 103443, 103444, 103500, 103501, 103503, 103521, 103524, 103531, 103532, 103543, 103549, 103560, 103586, 103598, 103626, 103654, 103700, 103708, 103720, 103728, 103736, 103749, 103755, 103775, 103790, 103792, 103794, 103854, 103857, 103858, 103859, 103871, 103872, 103874, 103887, 103888, 103913, 103945, 103954, 103960, 103961, 103971, 103984, 104014, 104035, 104081, 104151, 104161, 104168, 104180, 104185, 104191, 104228, 104272, 104338, 104342, 104370, 104371, 104372, 104387, 104389, 104453, 104460, 104461, 104481, 104609, 104615, 104616, 104617, 104634, 104659, 104665, 104896, 104907, 105072, 105104, 105110, 105150, 105151, 105185, 105219, 105220, 105226, 105233, 105241, 105349, 105508, 105510, 105633, 105638, 105644, 105646, 105662, 105721, 105743, 105899, 105901, 105949, 105957, 250002, 250057, 250090, 250100, 250126, 250137, 250166, 250196, 250221, 250413, 250439, 250480, 250677, 250678, 250693, 250754, 250779, 250780, 250827, 250846, 251096, 395962, 500001, 500037, 500039, 500040, 504115, 504117, 504122, 504355, 504524, 504607, 504610, 504668, 504673, 504731, 504761, 504811, 504844, 504910, 504938, 505011, 505053, 505055, 505137, 505138, 505452, 505512, 505661, 505733, 505757, 505775, 505810, 505814, 505904, 505963, 505967, 505988, 506022, 506066, 506074, 506156, 506157, 506187, 506193, 506214, 506320, 506323, 506332, 506333, 506525, 506526, 506799, 506800, 506831, 506833, 506834, 506838, 506840, 519113, 519119, 519140, 519144, 519146, 519529, 519551, 519565, 519731, 519732, 519734, 519736, 519775, 519803, 519816, 519871, 520048, 520063, 520184, 520242, 520282, 520410, 520531, 520576, 520581, 520669, 520764, 520770, 520772, 520775, 520846, 521104, 521107, 521127, 521327, 521371, 521377, 521378, 521382, 521383, 521384, 521385, 521395, 521449, 521450, 521455, 521522, 521583, 521604, 521649, 521671, 521681, 521688, 521709, 521870, 521871, 521898, 521936, 521964, 521979, 521994, 521996, 522132, 522179, 522206, 522242, 522251, 522356, 522357, 522436, 522442, 522476, 530406, 530429, 530515, 530574, 530576, 530610, 530620, 531650, 531711, 531746, 531751, 531775, 531778, 531854, 531855, 531859, 531933, 532067, 532072, 532082, 532110, 532146, 532147, 532289, 532291, 532423, 532474, 532480, 532775, 532776, 532778, 532781, 532802, 532829, 532841, 532982, 533115, 533178, 533237, 533239, 533245, 533248, 533249, 533300, 533310, 533311, 533330, 533331, 533352, 533472, 533474, 533475, 533524, 533544, 533555, 533557, 533564, 533692, 533715, 533765, 533777, 533789, 533901, 533902, 533919, 534187, 534201, 534209, 534240, 534243, 534244, 534245, 534261, 534272, 534304, 534408, 534417, 534421, 534422, 534425, 534426, 534429, 534487, 534586, 534602, 534605, 534606, 534607, 534608, 534641, 534642, 534670, 534780, 534804, 534823, 534831, 534846, 534849, 534997, 535214, 535219, 535234, 535249, 535270, 535369, 535377, 535417, 535423, 535430, 535431, 535432, 535433, 535434, 535435, 535438, 535452, 535453, 535454, 535455, 535456, 535457, 535458, 535499, 535666, 535721, 535747, 535758, 535760, 535784, 535910, 535922, 535960, 536012, 536013, 536050, 536402, 536429, 536432, 536474, 536613, 536619, 536630, 536644, 536663, 536707, 536766, 536797, 536800, 536822, 536825, 536837, 536838, 536904, 536934, 536967, 536968, 536980, 537047, 537051, 537054, 537131, 537330, 537447, 537465, 537556, 537587, 537632, 537645, 537696, 537893, 537894, 537923, 537942, 537969, 538006, 538064, 538066, 538100, 538137, 538140, 538155, 538268, 538317, 538352, 538363, 538450, 538513, 538515, 538518, 538527, 538581, 538855, 538856, 538864, 538900, 538978, 539023, 539024, 539025, 539026, 539027, 539028, 539029, 539039, 539091, 539092, 539093, 539163, 539164, 539173, 539182, 539620, 539631, 539724, 539725, 539863, 539881, 540011, 540028, 540055, 540081, 540087, 540096, 540097, 540098, 540135, 540157, 540158, 540164, 540175, 540178, 540200, 540216, 540260, 540262, 540268, 540366, 540431, 540446, 540467, 540473, 540501, 540502, 540503, 540506, 540762, 540858, 540970, 541064, 541068, 541089, 541175, 541179, 541242, 541243, 541244, 541264, 541270, 541323, 541327, 541351, 541497, 541514, 541536, 541586, 541644, 541692, 541733, 541744, 541764, 541837, 541914, X0101, X0389, X0568, X0715, X0971, X0976, X1040, X1070, X1143, X1156, X1157, X1182, X1183, X1195, X1196, X1200, X1208, X1209, X1211, X1212, X1217, X1220, X1225, X1226, X1265, X1276, X1285, X1291, X1292, X1303, X1311, X1331, X1332, X1334, X1336, X1337, X1359, X1360, X1361, X1400, X1406, X1415, X1416, X1421, X1422, X1423, X1427, X1470, X1560, X1597, X1610, X1651, X1652, X1658, X1660, X1667, X1682, X1701, X1702, X1727, X1728, X1748, X1754, X1773 Recalling Firm/ Manufacturer Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell , Washington 98021-8431 For Addition Information Contact Sarah Baxter 425-487-7665 Reason For Recall Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures. Action On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device. Quantity in Commerce 1,859 units Distribution Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH