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U.S. Department of Health and Human Services

Class 2 Device Recall MONOPLANE Xray Imaging Systems with Velara Generator

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 Class 2 Device Recall MONOPLANE Xray Imaging Systems with Velara Generatorsee related information
Date Initiated by FirmFebruary 04, 2010
Date PostedSeptember 22, 2010
Recall Status1 Terminated 3 on September 23, 2011
Recall NumberZ-2448-2010
Recall Event ID 56093
510(K)NumberK022899 K033737 K984545 
Product Classification System, X-Ray, Angiographic - Product Code IZI
ProductMONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane. The Monoplane system has one C-arm and it could be mounted on a ceiling or on the floor stand. The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".
Code Information Each unit is identified with a SITE number:  38358, 101952, 102560, 102564, 102730, 102923, 102948, 103128,  103265, 103275, 103289, 103331, 103380, 103525, 103561, 103562, 103564, 103696, 103729, 103751, 103780, 103781, 103927, 104060, 104075, 104106, 104139, 104149, 104464, 104501, 104512, 104514, 104515, 104536, 104642, 104668, 104670, 104890, 104925, 104927, 104952, 104954, 104955, 104956, 104957, 104958, 105073, 105081, 105082, 105100, 105136, 105137, 105139, 105140, 105153, 105156, 105157, 105186, 105191, 105304, 105343, 105386, 105390, 105402, 105409, 105583, 105598, 105615, 105631, 105655, 105656, 105670, 105674, 105684, 105686, 105742, 105779, 105784, 105866, 105908, 105912, 105917, 105940, 105946, 105947, 105950, 105951, 105952, 105953, 105961, 500004, 500028, 500029, 500038, 500041, 500042, 500052, 504344, 504493, 504636, 504638, 504646, 504659, 504665, 504666, 504730, 504747, 504750, 504769, 504770, 504776, 504789, 504792, 504795, 504797, 504798, 504806, 504807, 504871, 504872, 504903, 504904, 504908, 504913, 504915, 504916, 504920, 504940, 504977, 504988, 505008, 505017, 505064, 505106, 505107, 505111, 505135, 505250, 505252, 505254, 505270, 505271, 505281, 505363, 505421, 505424, 505486, 505520, 505538, 505546, 505572, 505587, 505650, 505651, 505668, 505679, 505680, 505706, 505719, 505759, 505803, 505804, 505805, 505807, 505809, 505860, 505861, 505886, 505925, 505968, 505989, 506009, 506047, 506048, 506049, 506060, 506121, 506148, 506169, 506170, 506178, 506222, 506225, 506230, 506232, 506322, 506369, 506370, 506397, 506403, 506408, 506462, 506469, 506476, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506654, 506657, 506658, 506693, 506778, 506785, 519115, 519179, 519195, 519198, 519199, 519211, 519212, 519213, 519214, 519533, 519534, 519535, 519536, 519537, 519541, 519548, 519576, 519594, 519673, 519676, 519677, 519680, 519733, 519738, 519767, 519771, 519812, 519874, 519894, 519899, 519901, 520004, 520147, 520189, 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531837, 531931, 531942, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532074, 532077, 532080, 532148, 532150, 532172, 532178, 532207, 532215, 532225, 532226, 532227, 532234, 532235, 532239, 532244, 532245, 532246, 532249, 532262, 532263, 532264, 532292, 532294, 532445, 532446, 532532, 532533, 532534, 532535, 532611, 532612, 532613, 532615, 532616, 532617, 532649, 532652, 532799, 532800, 532986, 532990, 533084, 533085, 533236, 533278, 533282, 533283, 533284, 533285, 533286, 533287, 533289, 533325, 533343, 533394, 533395, 533398, 533401, 533418, 533476, 533541, 533543, 533551, 533567, 533619, 533738, 533762, 533763, 533772, 533796, 533857, 533861, 533897, 533922, 533955, 533956, 533966, 533967, 534108, 534150, 534152, 534155, 534158, 534159, 534160, 534215, 534217, 534218, 534221, 534232, 534233, 534237, 534246, 534250, 534251, 534252, 534255, 534268, 534270, 534374, 534380, 534418, 534420, 534427, 534431, 534440, 534452, 534476, 534477, 534478, 534479, 534545, 534565, 534569.534627, 534630, 534634, 534638, 534639, 534646, 534665, 534678, 534681, 534682, 534716, 534717, 534720, 534724, 534730, 534731, 534743, 534758, 534787, 534796, 534798, 534811, 534813, 534856, 534874, 534876, 534879, 534927, 534928, 534941, 535094, 535151, 535152, 535173, 535212, 535213, 535224, 535250, 535274, 535278, 535285, 535303, 535326, 535342, 535348, 535367, 535376, 535387, 535396, 535400, 535415, 535416, 535418, 535424, 535439, 535492, 535566, 535611, 535614, 535615, 535635, 535667, 535702, 535727, 535728, 535769, 535772, 535777, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535979, 535982, 536006, 536007, 536014, 536030, 536067, 536090, 536136, 536138, 536154, 536155, 536163, 536173, 536174, 536178, 536234, 536379, 536425, 536433, 536471, 536592, 536639, 536641, 536646, 536714, 536717, 536721, 536736, 536777, 536796, 536798, 536801, 536901, 536921, 536954, 536966, 536993, 537020, 537024, 537065, 537073, 537118, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537588, 537589, 537590, 537597, 537604, 537630, 537644, 537698, 537717, 537731, 537743, 537745, 537784, 537805, 537810, 537838, 537854, 537855, 537922, 537934, 537935, 537937, 537938, 537985, 538084, 538102, 538193, 538194, 538228, 538234, 538269, 538322, 538368, 538369, 538386, 538404, 538406, 538416, 538432, 538449, 538464, 538465, 538466, 538476, 538479, 538482, 538485, 538486, 538512, 538537, 538538, 538744, 538771, 538806, 538813, 538902, 538903, 538910, 538911, 539094, 539099, 539107, 539204, 539220, 539224, 539267, 539268, 539322, 539323, 539369, 539380, 539381, 539398, 539455, 539456, 539472, 539479, 539480, 539516, 539595, 539634, 539641, 539745, 540048, 540070, 540082, 540150, 540167, 540203, 540209, 540213, 540234, 540235, 540269, 540275, 540284, 540288, 540301, 540311, 540312, 540321, 540325, 540338, 540374, 540386, 540421, 540456, 540460, 540468, 540487, 540488, 540622, 540684, 540790, 540808, 540841, 540887, 540912, 540930, 540952, 540973, 541026, 541029, 541030, 541046, 541047, 541049, 541053, 541080, 541223, 541251, 541253, 541259, 541409, 541509, 541510, 541572, 541588, 541592, 541597, 541657, 541659, 541667, 541715, 541742, 541748, 541783, 541822, 541848, 541873, 541880, 542109, 542113, 542117, 542306, 542478, 542486, 542518, 542522, 542526, 542744, 543087, 543108, 543194, 543198, 543209, 543213, 543216, 543229, 543386, 543397, 543398, 543399, 543408, 543433, 543610, 543611, 543702, 543759, 543762, 543799, 543829, 543850, 543873, 543877, 543931, 543971, 543972, 543984, 543988, 543999, 544005, 544048, 544051, 544052, 544057, 544086, 544103, 544120, 544122, 544130, 544145, 544184, 544371, 544433, 544489, 544506, 544513, 544550, 544572, 544581, 544600, 544610, 544631, 544636, 544637, 544655, 544728, 544729, 544750, 544989, 544990, 544992, 545023, 545024, 545037, 545052, 545069, 545073, 545090, 545280, 545282, 545293, 545295, 545296, 545357, 545365, 545395, 545443, 545521, 545539, 545640, 545714, 545733, 545749, 545750, 545752, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545905, 545912, 545921, 545941, 545942, 545964, 545966, 545975, 545985, 545991, 546012, 546014, 546025, 546060, 546201, 546456, 546517, 546560, 546561, 546572, 546585, 546586, 546634, 546668, 546679, 546693, 546886, 546908, 546934, 547005, 547058, 547118, 547159, 547165, 547234, 547279, 547287, 547321, 547334, 547364, 547392, 547406, 547600, 547601, 547619, 547620, 547621, 547627, 547628, 547660, 547700, 547720, 547729, 547748, 547749, 547753, 547761, 547762, 547763, 547770, 547775, 547777, 547795, 547800, 547822, 547833, 547838, 547852, 547855, 547861, 547878, 547893, 547896, 547898, 547908, 547914, 547918, 547921, 547925, 547932, 547948, 547952, 547965, 547976, 547977, 548022, 548029, 548038, 548039, 548049, 548051, 548054, 548061, 548067, 548108, 548147, 548192, 548432, 548496, 548525, 548601, 548603, 548616, 548640, 548645, 548660, 548764, 548775, 548778, 548785, 548966, 549013, 549170, 549245, 549250, 549252, 549253, 549264.549306, 549378, 549379, 549385, 549400, 549451, 549738, 549750, 549792, 549902, 549925, 549967, 550031, 550053, 550122, 550124, 550133, 550172, 550173, 550244, 550253, 550255, 550304, 550360, 550371, 550399, 550404, 550451, 551050, 551051, 551146, 551178, 551340, 551379, 551607, 551608, 551633, 551725, 551763, 551851, 551853, 552178, 552192, 552202, 552279, 552381, 552382, 552425, 552440, 552469, 552470, 552546, 552559, 552585, 552586, 552590, 552736, 553097, 553137, 553234, 553288, 553330, 553351, 553352, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553723, 553798, 553803, 553846, 553867, 553868, 553869, 553871, 553873, 553881, 553925, 553964, 553981, 553984, 554018, 554019, 554044, 554049, 554054, 554136, 554370, 554427, 554431, 554442, 554444, 554447, 554499, 554518, 554550, 554556, 554631, 554680, 554768, 554775, 554776, 554784, 554791, 554804, 554811, 554896, 555206, 555300, 555321, 555343, 555349, 555350, 555420, 555447, 555470, 555605, 555742, 555781, 555927, 556017, 556053, 556095, 556156, 556311, 556323, 556390, 556470, 556601, 556605, 556609, 556701, 556708, 556709, 556760, 556773, 556783, 556810, 556811, 556814, 556820, 556855, 556857, 556893, 557385, 557512, 557653, 558238, 558448, 558499, 558582, 560060,  41416356, 41416358, 41443581, 41443671, 41443700, 41443707, 41443774, 41443855, 41443882, 41443928, 41444385, 41444398, 41444399, 41444419, 41444446, 41444454, 41444461, 41444463, 41444558, 41444597, 41444603, 41444609, 41444646, 41444662, 41444680, 41444728, 41444743, 41444747, 41444753, 41444758, 41444791, 41444797, 41445001, 41445010, 41445014, 41445026, 41445032, 41445070, 41445119, 41445125, 41445169, 41445173, 41445202, 41445207, 41445229, 41445233, 41445235, 41445246, 41445250, 41445253, 41445254, 41445255, 41445256, 41445261, 41445270, 41445285, 41445303, 41445309, 41445310, 41445315, 41445332, 41445336, 41445344, 41445376, 41445377, 41445385, 41445390, 41445427, 41445434, 41445438, 41445452, 41445486, 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42394081, 42478916, 42508767, 42552595, 42635362, 42635423, 42635426, 42638228, 42638512, 42638525, 42639096, 42668010, 42799507, 42799589, 42799745, 42802803, 42811500, 42812038, 42816302, 42823758, 42826856, 42826863, 42878485, 42881036, 42881266, 42892018, 42892404, 42892430, 42892474, 42919054, 42919085, 42967816, 42985101, 42985218, 43067304, 43082276, 43084042, 43084220, 43084414, 43119111, 43120325, 43151051, 43165011, 43179280, 43180544, 43209312, 43209348, 43209356, 43209360, 43230259, 43259235, 43263118, 43270340, 43305020, 43320930, 43340698, 43392727, 43420965, 43421081, 43433587, 43438771, 43443629, 43445198, 43446897, 43592438, 43594036, 43594037, 43613819, 43618965, 43622121, 43689832, 43704085, 43708891, 43709318, 43718660, 43719245, 43720499, 43720519, 43720660, 43720677, 43720776, 43721160, 43721227, 43721256, 43721670, 43756720, 43848518, 43902667, 43914262, 43931289, 43971849, 43973609, 43973613, 44004308, 44004309, 44015656, 44026775, 44035662, 44038398, 44065220, 44203373, 44320671, 44339387, 44388661, 44450326, 44536044, 44536281, 44604746, 44620455, 44621056, 44642682, 44643966, 44644567, 44649231, 44650811, 44654610, 44654626, 44654678, 44654764, 44743567, 44743568, 44830153, 44866223, 44879032, 44881204, 44891499, 45072647, 45103403, 45109943, 45168574, 45217802, 45321194, 45405221, 45412976, 45414258, 45428128, 45428705, 45428708, 45485899, 45509016, 45632472, 45632486, 47158877, 47312619, 49599010, 49599013,  and 49599014.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information ContactBob Pettis
425-487-7602
Manufacturer Reason
for Recall		A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator are damaged and the system can not be restarted.
FDA Determined
Cause 2		Software design
ActionOn 02/04/2010, Philips Healthcare began sending out the URGENT-Device Correction Notices to their consignees. The firm issued two notifications, one for the Allura Integris and Xper FD10C, FD10F, FD10F/C and FD20 Monoplane X-Ray imaging systems with the Velara Generator. The second notification is for the Allura Integris Xper FD10 and FD20 Biplane X-ray imaging systems with the Velara Generator. This notice informs the consignees that a system locks up during a critical interventional case and it might impose a serious injury to patients. This lock up issue could only be resolved by a warm or cold system restart. A warm restart would take about 90 seconds or a cold restart would take about four minutes, and the device could not be used during this time. If the system does not work after the restart, the consignees should contact the Philips Healthcare Customer Service Representative at 1-800-772-9377 #5 (then follow prompts). A service representative will visit each consignee and conduct a software and hardware upgrade.
Quantity in Commerce1470 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZI
510(K)s with Product Code = IZI
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