Philips Medical Systems North America Co. Phillips: 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.

Recall number

Z-2476-2010

Recalling firm

Philips Medical Systems North America Co. Phillips

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.

Status

Terminated

Initiated

2008-10-23

Posted

2010-09-22

Terminated

2011-08-10

Reason

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.

Root 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

838 units in US

Distribution

Worldwide distribution.

Lot, serial or model codes

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.

510(k) numbers

["K033737"]

PMA numbers

not on file

Product code

IZI

Firm FEI

1000524572

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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