Device Recall MONOPLANE Xray Imaging Systems with Velara Generator

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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".
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA