MONOPLANE 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".
This recall has been terminated (originally issued September 22, 2010).
- Recall Initiated
- February 4, 2010
- Posted
- September 22, 2010
- Terminated
- September 23, 2011
- Recall Number
- Z-2448-2010
- Quantity
- 1470 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
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, 520236, 520251, 520309, 520319, 520430, 520431, 520481, 520491, 520517, 520523, 520524, 520525, 520526, 520598, 520630, 520631, 520632, 520660, 520680, 520681, 520755, 520761, 520779, 520783, 520809, 520814, 520840, 520882, 520948, 520956, 520977, 521001, 521131, 521154, 521222, 521223, 521310, 521311, 521312, 521313, 521314, 521315, 521318, 521320, 521463, 521512, 521537, 521545, 521548, 521562, 521589, 521650, 521659, 521661, 521675, 521711, 521763, 521769, 521770, 521802, 521820, 521853, 521854, 521890, 521892, 521918, 522038, 522065, 522118, 522119, 522135, 522138, 522162, 522177, 522191, 522224, 522243, 522245, 522247, 522250, 522293, 522397, 522418, 522440, 522446, 522458, 530361, 530368, 530370, 530390, 530391, 530392, 530393, 530421, 530459, 530460, 530463, 530464, 530466, 530485, 530584, 530655, 530656, 530658, 530662, 530663, 530664, 530666, 530667, 530668, 530669, 530715, 530783, 531651, 531728, 531752, 531753, 531760, 531762, 531805, 531806, 531808, 531813, 531817, 531834, 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, 41445495, 41445502, 41445514, 41445515, 41445516, 41445578, 41445582, 41445616, 41445645, 41445676, 41445677, 41445692, 41445701, 41445744, 41445766, 41445785, 41445804, 41445809, 41445816, 41445817, 41445875, 41445916, 41445978, 41445989, 41446007, 41446024, 41446039, 41446044, 41446080, 41446117, 41446144, 41446150, 41446211, 41446212, 41446216, 41446217, 41446223, 41446277, 41446290, 41446292, 41446323, 41446363, 41446796, 41446807, 41446808, 41455880, 41455893, 41455894, 41455896, 41455900, 41455902, 41455906, 41455910, 41455924, 41455932, 41455955, 41586608, 41612034, 41622975, 41630856, 41691748, 41747146, 41755552, 41765492, 41779600, 41779610, 41787786, 41792527, 41792800, 41792812, 41793875, 41793888, 41795224, 41796153, 41851761, 41903418, 41903960, 41956849, 42028108, 42038023, 42046538, 42057714, 42057739, 42063953, 42066520, 42067846, 42095488, 42172062, 42197144, 42206171, 42225697, 42288802, 42304719, 42313004, 42323439, 42365781, 42366186, 42371287, 42393465, 42393532, 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.
Root Cause
Software design
Action Taken
On 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.