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U.S. Department of Health and Human Services

Class 2 Device Recall Allura XPER FD20

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 Class 2 Recall
Allura XPER FD20
see related information
Date Posted September 24, 2009
Recall Status1 Open
Recall Number Z-0349-2009
Recall Event ID 50742
Premarket Notification
510(K) Numbers
K022899  K031333  K033737  K984545 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Allura XPER FD20
Code Information FCO 72200107, 72200112, and 72200117 for 1st phase 72200132 for 2nd phase Equipment #'s 86914, 102166, 103282, 103380, 105294, 105670, 505876, 506539, 506540, 506778, 519195, 519894, 520319, 520491, 520598, 520630, 520631, 520632, 520660, 520755, 520779, 520783, 520814, 520948, 520977, 521001, 521154, 521222, 521311, 521312, 521314, 521315, 521512, 521548, 521589, 521659, 521675, 521820, 521890, 522397, 530368, 530391, 530392, 530485, 530584, 530663, 530664, 530666, 530715, 530783, 531728, 531752, 531760, 531762, 531808, 531817, 531830, 531834, 531931, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532077, 532150, 532207, 532225, 532227, 532239, 532244, 532245, 532249, 532262, 532263, 532264, 532294, 532532, 532533, 532649, 532990, 533084, 533284, 533285, 533287, 533325, 533395, 533398, 533543, 533551, 533738, 533763, 533772, 533857, 533897, 533955, 533956, 533966, 534108, 534131, 534150, 534152, 534158, 534215, 534217, 534232, 534246, 534250, 534255, 534269, 534270, 534374, 534380, 534418, 534420, 534431, 534452, 534545, 534565, 534569, 534639, 534646, 534665, 534682, 534716, 534720, 534724, 534730, 534787, 534796, 534798, 534810, 534811, 534856, 534927, 535094, 535151, 535152, 535173, 535213, 535274, 535278, 535285, 535303, 535367, 535376, 535396, 535418, 535424, 535439, 535492, 535566, 535611, 535615, 535635, 535702, 535727, 535772, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535982, 536006, 536007, 536014, 536030, 536067, 536136, 536154, 536155, 536163, 536173, 536174, 536178, 536234, 536433, 536471, 536592, 536641, 536646, 536714, 536717, 536736, 536796, 536798, 536801, 536901, 536921, 536954, 536993, 537024, 537073, 537118, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537590, 537597, 537604, 537717, 537743, 537784, 537805, 537810, 537838, 537854, 537922, 537934, 537938, 537985, 538102, 538193, 538194, 538228, 538234, 538322, 538369, 538386, 538404, 538406, 538449, 538464, 538465, 538466, 538479, 538482, 538512, 538538, 538771, 538813, 538902, 538910, 538911, 539094, 539204, 539220, 539267, 539268, 539322, 539323, 539369, 539380, 539381, 539398, 539456, 539472, 539479, 539634, 539745, 540048, 540082, 540150, 540167, 540203, 540209, 540213, 540275, 540284, 540288, 540312, 540321, 540325, 540338, 540374, 540421, 540456, 540460, 540487, 540622, 540684, 540721, 540790, 540808, 540887, 540912, 540930, 540952, 540973, 541030, 541046, 541047, 541049, 541053, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541509, 541572, 541659, 541715, 541742, 541748, 541783, 541848, 541873, 541880, 542306, 542382, 542478, 542486, 542518, 542522, 542526, 542744, 543087, 543213, 543216, 543229, 543386, 543397, 543398, 543399, 543444, 543611, 543759, 543762, 543799, 543850, 543877, 543931, 543971, 543972, 543984, 544005, 544052, 544057, 544086, 544103, 544120, 544130, 544184, 544371, 544489, 544513, 544550, 544581, 544631, 544636, 544655, 544728, 544729, 544750, 544989, 545024, 545073, 545090, 545262, 545280, 545282, 545293, 545295, 545521, 545539, 545640, 545714, 545733, 545749, 545750, 545752, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545905, 545912, 545921, 545941, 545964, 545975, 545985, 545991, 546014, 546025, 546060, 546201, 546456, 546517, 546585, 546586, 546634, 546668, 546679, 546693, 546886, 546908, 547005, 547058, 547118, 547234, 547287, 547334, 547364, 547392, 547601, 547619, 547620, 547621, 547627, 547628, 547700, 547720, 547729, 547748, 547753, 547770, 547775, 547777, 547795, 547800, 547822, 547833, 547838, 547852, 547855, 547861, 547893, 547896, 547898, 547918, 547921, 547925, 547932, 547948, 547952, 547976, 547977, 548022, 548029, 548039, 548049, 548051, 548054, 548061, 548108, 548192, 548496, 548601, 548616, 548640, 548660, 548764, 548775, 548778, 548785, 549170, 549245, 549250, 549252, 549253, 549264, 549306, 549378, 549379, 549385, 549750, 549902, 549925, 549967, 550031, 550053, 550122, 550133, 550173, 550244, 550253, 550304, 550371, 550399, 550404, 550451, 551050, 551051, 551146, 551178, 551340, 551370, 551607, 551608, 551725, 551763, 551851, 551853, 552178, 552192, 552202, 552279, 552381, 552382, 552425, 552440, 552469, 552546, 552590, 552736, 553097, 553288, 553330, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553723, 553798, 553803, 553846, 553867, 553868, 553869, 553871, 553873, 553881, 553984, 554008, 554018, 554044, 554049, 554054, 554136, 554370, 554447, 554518, 554680, 554731, 554763, 554775, 554776, 554784, 554811, 555300, 555321, 555343, 555349, 555350, 555420, 555447, 555461, 555470, 555588, 555742, 555927, 556017, 556095, 556156, 556203, 556323, 556389, 556390, 556470, 556601, 556605, 556609, 556701, 556709, 556760, 556810, 556811, 556814, 556820, 556855, 556857, 556893, 557653, 557808, 558238, 558448, 558499, 558582, 558831, 558832, 558949, 41416356, 41443671, 41443928, 41444385, 41444398, 41444603, 41444646, 41444743, 41444747, 41444758, 41444791, 41444797, 41445010, 41445014, 41445070, 41445169, 41445202, 41445207, 41445261, 41445285, 41445309, 41445310, 41445385, 41445438, 41445452, 41445495, 41445502, 41445516, 41445582, 41445640, 41445649, 41445692, 41445701, 41445785, 41445786, 41445809, 41445817, 41445875, 41445978, 41445989, 41446007, 41446039, 41446117, 41446217, 41446223, 41446277, 41446292, 41446323, 41446808, 41455893, 41455896, 41455900, 41455902, 41455910, 41455924, 41455955, 41691748, 41755552, 41787786, 41792800, 41792812, 41793875, 41796153, 41851761, 41956849, 42028108, 42038023, 42057714, 42067696, 42095488, 42172062, 42197144, 42206171, 42288802, 42313004, 42365781, 42366186, 42552595, 42638525, 42668010, 42826856, 42826863, 42985101, and 43082872. Additional Equipment #s for Phase 2 - 10440, 10441, 14145, 38358, 38925, 41272, 50438, 76378, 80320, 82537, 84721, 86066, 86290, 86989, 100503, 100683, 100708, 100713, 100948, 101139, 101606, 101607, 101966, 102563, 102776, 103144, 103231, 103287, 103957, 104056, 104077, 504315, 546465, 555781, 557790, 557809, 557841, 557956, 558199, 560060, 36190293, 41443700, 41443707, 41443774, 41443855, 41444399, 41444446, 41444463, 41444558, 41444597, 41444753, 41445026, 41445119, 41445125, 41445233, 41445246, 41445254, 41445255, 41445256, 41445315, 41445336, 41445427, 41445434, 41445486, 41445578, 41445616, 41445676, 41445804, 41445916, 41446044, 41446150, 41446211, 41446363, 41446796, 41586608, 41630856, 41765492, 41779600, 41779610, 41792527, 42046538, 42063953, 42066520, 42225697, 42323439, 42394081, 42473102, 42478916, 42635362, 42635423, 42635426, 42638228, 42638512, 42811500, 42812038, 42823758, 42878485, 42878591, 42881036, 42881266, 42892018, 42892430, 42892474, 42919054, 42919085, 42967816, 42985218, 43082276, 43084042, 43084414, 43119111, 43120325, 43165011, 43180544, 43209312, 43209348, 43209356, 43230259, 43263118, 43320930, 43340698, 43392727, 43420965, 43421081, 43433587, 43438771, 43443629, 43445198, 43592438, 43594036, 43594037, 43613819, 43618965, 43622121, 43704085, 43708891, 43720519, 43720677, 43720776, 43721160, 43721256, 43848518, 43914262, 43971849, 43973609, 43973613, 44004308, 44004309, 44015656, 44038398, 44203373, 44642682, 44891499, 47455986, and 49408181.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Manufacturer Reason
for Recall
Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C.
Quantity in Commerce 835 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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