Class 2 Device Recall Allura XPER FD20

• Date Initiated by Firm: October 23, 2008
• Date Posted: September 22, 2010
• Recall Status: Terminated on August 10, 2011
• Recall Number: Z-2476-2010
• Recall Event ID: 50114
• 510(K)Number: K033737
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabinet).; Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
• Code Information: Devices are identified with Site Numbers: 41444385, 41444747, 41445014, 41445202, 41445207, 41445452, 41445502, 41445516, 41445640, 41445649, 41445785, 41445817, 41446217, 41446323, 41455893, 41455896, 41446039, 41443671, 41691748, 41755552, 41792812, 41793875, 41796153, 41956849, 42028108, 42038023, 42172062, 42206171, 41445978, 41455955, 41787786, 42057714, 42067696, 42095488, 42313004, 42366186, 42552595, 42668010, 534545, 543877, 548640, 554763, 556814, 42638525, 41445261, 42197144, 42365781, 521589, 519195, 506540, 519894, 506539, 105670, 521001, 520977, 521890, 520755, 520632, 521675, 531946, 520779, 531752, 521154, 521548, 521311, 534639, 521314, 521315, 521312, 520814, 532262, 521512, 520660, 530391, 530392, 521659, 520319, 103380, 530485, 535615, 530663, 522397, 531760, 531948, 535492, 531961, 540973, 531728, 531762, 530783, 531830, 532077, 531944, 531808, 530715, 531931, 531834, 531957, 532249, 532150, 531951, 530584, 532244, 532264, 521820, 532294, 532533, 532263, 535326, 533395, 532225, 532649, 520783, 534569, 532990, 534150, 530664, 532532, 530368, 533738, 532227, 533772, 532245, 533897, 534250, 533543, 534811, 538194, 534565, 533084, 534810, 534232, 534108, 531817, 534215, 535727, 534431, 533551, 533285, 542306, 532239, 535151, 534856, 534380, 535152, 534720, 534246, 537118, 534545, 534798, 533857, 531943, 534217, 534730, 534796, 537466, 536163, 534152, 534158, 531945, 534418, 520948, 535396, 533325, 531949, 535173, 535418, 534716, 521222, 535424, 535285, 535274, 535278, 535611, 534255, 535779, 535635, 536796, 535814, 534270, 535094, 534787, 535439, 534420, 535927, 535946, 536174, 535376, 535793, 536173, 535702, 536234, 533763, 535813, 536178, 534724, 536471, 536433, 535566, 536592, 536067, 537024, 536993, 534452, 536901, 536006, 536717, 536736, 535772, 536921, 534682, 536136, 535931, 536007, 536641, 536646, 537357, 536798, 535367, 538102, 536154, 536155, 537934, 537205, 533284, 537386, 537922, 533966, 533955, 533956, 538538, 535951, 537073, 537597, 534374, 537266, 537784, 537805, 539094, 536714, 538386, 538193, 538234, 536014, 537717, 537985, 538466, 538479, 538369, 538406, 538771, 538482, 538464, 538228, 540048, 539204, 538813, 538902, 539323, 539322, 539472, 539220, 533287, 539267, 538465, 540082, 537810, 540622, 540288, 538449, 539398, 539369, 539479, 540421, 537743, 539745, 538512, 540487, 534646, 539380, 543444, 537296, 540209, 541253, 540887, 539381, 537268, 540912, 537514, 536954, 538322, 540338, 534269, 541049, 536801, 541251, 541715, 541259, 541848, 541223, 541030, 540684, 541873, 542478, 538404, 540167, 542744, 540150, 543762, 536641, 102166, 530666, 538095, 538099, 520491, 541238, 520630, 541239, 541276, 521001, 541237, 540721, 542382, 539213, 520598, 521548, 531946, 521154, 521312, 544543, 532262, 521512, 545262, 545583, 546119, 534131, 535492, 534156, 531944, 531957, 532150, 530584, 533395, 532990, 534150, 532532, 532227, 533772, 533897, 534250, 533543, 538194, 534565, 534810, 534215, 533551, 533285, 532239, 535151, 534856, 534380, 534798, 533857, 534217, 534730, 537466, 534152, 534158, 531945, 534418, 535396, 535173, 534716, 535274, 535278, 535611, 534255, 535779, 535635, 536796, 534270, 535094, 534787, 535439, 534420, 535927, 535376, 536173, 535702, 533763, 536471, 536433, 536592, 536067, 537024, 536993, 536901, 536717, 536736, 536007, 536646, 537357, 538102, 537205, 533284, 537386, 537922, 537266, 533966, 533955, 533956, 538538, 535951, 537073, 534374, 539094, 536714, 538386, 41455897, 538466, 538479, 538406, 538771, 538482, 538228, 540048, 538813, 538902, 539220, 533287, 537810, 540288, 538449, 534665, 539745, 539380, 543444, 540209, 541253, 539381, 537268, 537514, 538322, 540338, 541049, 541251, 541715, 541848, 541030, 541873, 540167, 542744, 543762, 545024, 550371, 552178, 553432, 538465, 536178, 86914, 521589, 521315, 105670, 520660, 521675, 522397, 520779, 531961, 531760, 531830, 532077, 103282, 520631, 552469, 551763, 553603, 553487, 554136, 554447, 553869, 506539, 553445, 539369, 540887, 534811, 540203, 544052, 538193, 540487, 534246, 547948, 547627, 534452, 535931, 546886, 551178, 539322, 547720, 544636, 544655, 551608, 534431, 550253, 520783, 552192, 535727, 552425, 537805, 547620, 547619, 553881, 553871, 553873, 553723, 553798, 554044, 553867, 553868, 554018, 553397, 554370, 549264, 554054, 547770, 554680, 550399, 554763, 552736, 554811, 553984, 555420, 554775, 548051, 548049, 553803, 41445285, 555349, 555350, 555356, 553097, 550133, 555447, 555343, 555321, 554518, 554049, 552279, 41444758, 553486, 555927, 553846, 554776, 550031, 41445010, 41445070, 556156, 556323, 553466, 547838, 556470, 548660, 547753, 556095, 556820, 41455910, 41444646, 556857, 556605, 556810, 555300, 556701, 556390, 556814, 555470, 556760, 555742, 41445989, 41445692, 556017, 553288, 556855, 556609, 556709, 41446277, 556893, 41444791, 556601, 557653, 558238, 558448, 558499, 41443928, 41445310, 41446117, 558582, 41455924, 41446007, 554784, 41445495, 41444743, 41445385, 41446223, 41444398, 41444797, 41445809, 41446292, 41446808, 41445169, 41455900, 41445438, 41445701, 41445309, 41455902, 41444603, 556811, 41445582, 42288802, 41445875, 41445786, 41792800, 41851761, 41416356, 544184, 532207, 536030, 535982, 533398, 537838, 540973, 534927, 541748, 535213, 540790, 541509, 537604, 541742, 540213, 543216, 543213, 551370, 544550, 540312, 544005, 542526, 543931, 540284, 541572, 543799, 543087, 541046, 537854, 540952, 540930, 544371, 540456, 542486, 544489, 544086, 544057, 539456, 541047, 544750, 543386, 539634, 544513, 540808, 541880, 544130, 543759, 544581, 543611, 545282, 543229, 543984, 545293, 544728, 544989, 545090, 545640, 545280, 545749, 540275, 541783, 544631, 545752, 545714, 545964, 545838, 545840, 545839, 545799, 545733, 543972, 545941, 545539, 545073, 546060, 543971, 545827, 543877, 546025, 546014, 540374, 546456, 545975, 545921, 544120, 545912, 546693, 535303, 540321, 540325, 546668, 547005, 545750, 536801, 538481, 546586, 541659, 542522, 542518, 547234, 536798, 547364, 545905, 547392, 536954, 541053, 536174, 546908, 546585, 547628, 521820, 547334, 546201, 547852, 547952, 531808, 537118, 548039, 547976, 547700, 543399, 543397, 543398, 547921, 548054, 547777, 547855, 547775, 537938, 547898, 547833, 547861, 548022, 548061, 546517, 553697, 548785, 548640, 548496, 548616, 547729, 543850, 544103, 544729, 540460, 545991, 546634, 545295, 549170, 537590, 538911, 538910, 547932, 550758, 549253, 547287, 548108, 549245, 548775, 547601, 547621, 549250, 547058, 545985, 549306, 547977, 547896, 547893, 549967, 550053, 504674, 549378, 548764, 548029, 539268, 550173, 549750, 547925, 547918, 550404, 549902, 550122, 548432, 550451, 547748, 548778, 506778, 550244, 549925, 550304, 545779, 545776, 545521, 551146, 545853, 548601, 547800, 551050, 551051, 549379, 551340, 551725, 551853, 551851, 547118, 552202, 547795, 552381, 552382, 505876, 549385, 552440, 552546, 552590, 547822, and 551607.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Call Center; 800-722-9377
• Manufacturer Reason for Recall: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.
• FDA Determined Cause: Other
• Action: The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.
• Quantity in Commerce: 838 units in US
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.