Z-0907-2007
Philips Bucky DIagnost X-Ray System
Philips North America LLC / initiated 2007-07-23 / Terminated
Philips Medical Systems North America Co. Phillips began a recall of Philips Bucky DIagnost X-Ray System on . The reason FDA records is "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". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0907-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- Product
- Philips Bucky DIagnost X-Ray System
- Product code
- KPR System, X-Ray, Stationary
- 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.
- FDA root cause
- Other
- 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 + 65 units added = 1924
- Distribution
- Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
- Product codes and lots
- 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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.