—#64513

Product

Philips Bucky DIagnost X-Ray System

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K945278
Affected lot / code info: Site 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, 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, 101437, 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. Added units - 13917, 13919, 17621, 26030, 26294, 37950, 38435, 38542, 38715, 38975, 50319, 50320, 62972, 76374, 76802, 82617, 82941, 83604, 83956, 85495, 85697, 86223, 86314, 86325, 86382, 86383, 86451, 87048, 100322, 100693, 102024, 102899, 103278, 103330, 103976, 105195, 105659, 250501, 250682, 428142, 505037, 505659, 506491, 506694, 520036, 520850, 532072, 532142, 532143, 532473, 536708, 543134, 545861, 549615, 550969, 554417, 557854, 557990, 558090, 558215, 558218, 558219, 558220, 558221, and 558222.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.

Timeline

Recall initiated: 2007-07-23
Posted by FDA: 2007-09-25
Terminated: 2012-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.