Events

Rappel de Allura Xper Systems with Velara Generator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Co. Phillips.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57777
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1654-2011
  • Date de mise en oeuvre de l'événement
    2010-10-07
  • Date de publication de l'événement
    2011-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97385
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    x-ray system. - Product Code IZI
  • Cause
    A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
  • Action
    On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.

Device

Allura Xper Systems with Velara Generator
  • Modèle / numéro de série
    Site Numbers:  10105, 10440, 10441, 10455, 10483, 13914, 13997, 14147, 38358, 38378, 38532, 50438, 52463, 62891, 80327, 82537, 84468, 86008, 86066, 86196, 86290, 86914, 86985, 86989, 100683, 101139, 101159, 101205, 101966, 102166, 102563, 102776, 103281, 103283, 103381, 103445, 103554, 103564, 103927, 104077, 104149, 104201, 104416, 104978, 105139, 105140, 105186, 105294, 105386, 105402, 105598, 105674, 105686, 250674, 504730, 504797, 504798, 504806, 504807, 504908, 505106, 505107, 505281, 505546, 505572, 505680, 505707, 505876, 506119, 506476, 506539, 506540, 506564, 506778, 506785, 519195, 519198, 519214, 519533, 519989, 520319, 520680, 520761, 520779, 520783, 520840, 520948, 521001, 521222, 521223, 521311, 521312, 521318, 521512, 521537, 521545, 521562, 521589, 521659, 521661, 521711, 521763, 521820, 521853, 521854, 522138, 522177, 522243, 522245, 522250, 522293, 522396, 522397, 522418, 522440, 522446, 522458, 530361, 530368, 530370, 530390, 530391, 530392, 530393, 530421, 530485, 530584, 530654, 530655, 530662, 530663, 530664, 530666, 530667, 530669, 530715, 530783, 531651, 531753, 531760, 531762, 531805, 531806, 531808, 531813, 531817, 531830, 531834, 531837, 531926, 531931, 531942, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532074, 532077, 532080, 532150, 532178, 532207, 532215, 532225, 532226, 532227, 532235, 532239, 532241, 532244, 532245, 532246, 532249, 532262, 532263, 532264, 532292, 532294, 532445, 532446, 532532, 532533, 532534, 532535, 532611, 532612, 532613, 532614, 532615, 532616, 532617, 532649, 532652, 532799, 532800, 532986, 532990, 533084, 533085, 533236, 533278, 533282, 533283, 533284, 533285, 533286, 533287, 533289, 533325, 533343, 533395, 533397, 533398, 533401, 533418, 533476, 533543, 533551, 533619, 533738, 533762, 533763, 533772, 533796, 533857, 533861, 533897, 533922, 533955, 533956, 533966, 533967, 534108, 534150, 534152, 534156, 534158, 534160, 534215, 534217, 534218, 534221, 534232, 534233, 534237, 534246, 534250, 534251, 534255, 534268, 534269, 534270, 534374, 534380, 534418, 534420, 534427, 534431, 534440, 534452, 534476, 534477, 534478, 534479, 534545, 534565, 534569, 534630, 534634, 534638, 534639, 534646, 534665, 534678, 534681, 534682, 534716, 534717, 534720, 534724, 534730, 534731, 534743, 534758, 534787, 534796, 534798, 534810, 534811, 534813, 534856, 534874, 534876, 534927, 534928, 534941, 535094, 535151, 535152, 535173, 535212, 535213, 535224, 535250, 535274, 535278, 535285, 535303, 535326, 535342, 535367, 535376, 535396, 535400, 535415, 535416, 535418, 535424, 535439, 535492, 535566, 535611, 535614, 535615, 535635, 535667, 535702, 535727, 535728, 535769, 535772, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535979, 535982, 536006, 536007, 536014, 536028, 536030, 536031, 536034, 536035, 536037, 536042, 536067, 536090, 536136, 536138, 536154, 536155, 536163, 536171, 536173, 536174, 536178, 536234, 536379, 536425, 536433, 536471, 536592, 536639, 536641, 536646, 536714, 536715, 536717, 536721, 536736, 536777, 536789, 536798, 536801, 536899, 536901, 536921, 536954, 536966, 536993, 537020, 537024, 537065, 537073, 537205, 537266, 537268, 537296, 537357, 537386, 537514, 537588, 537589, 537590, 537597, 537604, 537630, 537631, 537644, 537698, 537717, 537743, 537745, 537784, 537804, 537805, 537810, 537838, 537854, 537855, 537922, 537934, 537935, 537937, 537938, 537985, 538028, 538084, 538095, 538099, 538102, 538157, 538193, 538228, 538234, 538269, 538322, 538368, 538369, 538386, 538387, 538404, 538406, 538409, 538416, 538432, 538449, 538464, 538465, 538466, 538476, 538479, 538482, 538485, 538486, 538512, 538514, 538516, 538744, 538771, 538813, 538902, 538903, 538910, 538911, 539099, 539107, 539204, 539213, 539220, 539224, 539267, 539268, 539322, 539323, 539326, 539369, 539380, 539381, 539398, 539455, 539456, 539472, 539479, 539480, 539516, 539595, 539628, 539634, 539641, 539745, 540048, 540070, 540082, 540150, 540167, 540184, 540203, 540209, 540213, 540234, 540235, 540237, 540269, 540275, 540284, 540288, 540301, 540311, 540312, 540321, 540325, 540338, 540374, 540386, 540421, 540456, 540460, 540461, 540487, 540488, 540622, 540684, 540721, 540790, 540808, 540841, 540887, 540912, 540930, 540952, 541026, 541029, 541030, 541046, 541047, 541049, 541053, 541080, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541276, 541409, 541509, 541510, 541572, 541577, 541588, 541589, 541590, 541592, 541597, 541657, 541659, 541667, 541715, 541742, 541748, 541783, 541822, 541848, 541873, 541880, 542109, 542113, 542117, 542306, 542382, 542413, 542478, 542486, 542518, 542522, 542526, 542557, 542714, 542744, 542963, 543087, 543108, 543194, 543198, 543209, 543213, 543216, 543229, 543289, 543386, 543397, 543398, 543399, 543411, 543433, 543444, 543610, 543611, 543690, 543702, 543759, 543762, 543799, 543829, 543850, 543873, 543877, 543879, 543931, 543953, 543971, 543972, 543984, 543988, 543989, 543999, 544005, 544048, 544051, 544052, 544057, 544086, 544103, 544120, 544122, 544130, 544145, 544184, 544306, 544371, 544395, 544433, 544489, 544506, 544513, 544543, 544550, 544572, 544581, 544600, 544610, 544631, 544635, 544636, 544637, 544655, 544656, 544668, 544728, 544729, 544750, 544844, 544989, 544990, 544992, 545023, 545024, 545025, 545037, 545052, 545069, 545073, 545090, 545262, 545280, 545282, 545293, 545295, 545296, 545357, 545365, 545395, 545396, 545443, 545518, 545521, 545539, 545583, 545604, 545640, 545714, 545733, 545749, 545750, 545752, 545753, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545884, 545905, 545921, 545941, 545942, 545964, 545966, 545975, 545985, 545991, 545997, 546012, 546013, 546014, 546025, 546060, 546119, 546149, 546201, 546456, 546517, 546560, 546561, 546569, 546572, 546585, 546586, 546634, 546668, 546679, 546693, 546886, 546906, 546908, 546934, 547005, 547058, 547118, 547159, 547165, 547173, 547215, 547234, 547279, 547287, 547321, 547334, 547364, 547392, 547406, 547431, 547600, 547601, 547619, 547620, 547621, 547627, 547628, 547642, 547660, 547700, 547715, 547720, 547729, 547748, 547749, 547753, 547761, 547762, 547763, 547769, 547770, 547775, 547777, 547795, 547800, 547822, 547823, 547833, 547838, 547852, 547855, 547861, 547878, 547893, 547896, 547898, 547908, 547914, 547918, 547921, 547922, 547925, 547932, 547948, 547952, 547965, 547976, 547977, 548005, 548020, 548022, 548029, 548036, 548038, 548039, 548049, 548051, 548054, 548061, 548067, 548082, 548108, 548147, 548192, 548288, 548383, 548432, 548496, 548525, 548601, 548603, 548616, 548618, 548640, 548645, 548660, 548764, 548775, 548778, 548785, 548966, 549013, 549170, 549202, 549242, 549245, 549250, 549252, 549253, 549264, 549306, 549368, 549370, 549378, 549379, 549385, 549400, 549451, 549738, 549750, 549792, 549832, 549902, 549903, 549925, 549967, 550031, 550053, 550122, 550124, 550133, 550172, 550173, 550198, 550244, 550253, 550255, 550304, 550360, 550371, 550399, 550404, 550451, 550691, 550758, 550812, 550935, 551050, 551051, 551146, 551178, 551340, 551379, 551607, 551608, 551633, 551725, 551763, 551851, 551853, 551855, 552178, 552192, 552202, 552279, 552355, 552381, 552382, 552425, 552440, 552469, 552470, 552546, 552559, 552585, 552586, 552590, 552599, 552639, 552736, 552969, 553097, 553137, 553234, 553288, 553351, 553352, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553685, 553697, 553699, 553723, 553766, 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, 554745, 554763, 554768, 554775, 554776, 554784, 554791, 554802, 554804, 554811, 554896, 554970, 555206, 555293, 555299, 555300, 555321, 555343, 555349, 555350, 555356, 555420, 555447, 555461, 555470, 555588, 555605, 555742, 555781, 555834, 555927, 556017, 556053, 556095, 556156, 556311, 556323, 556389, 556390, 556470, 556601, 556605, 556609, 556701, 556708, 556709, 556760, 556773, 556783, 556810, 556811, 556814, 556820, 556855, 556857, 556885, 556893, 557385, 557512, 557653, 557729, 557790, 557808, 557809, 557908, 557956, 558238, 558448, 558499, 558582, 558604, 558831, 558832, 558945, 560060, 41416356, 41416358, 41443581, 41443586, 41443609, 41443627, 41443647, 41443671, 41443700, 41443707, 41443727, 41443765, 41443774, 41443804, 41443855, 41443882, 41443909, 41443928, 41444385, 41444398, 41444399, 41444419, 41444446, 41444454, 41444461, 41444463, 41444556, 41444558, 41444597, 41444603, 41444609, 41444645, 41444646, 41444647, 41444650, 41444662, 41444680, 41444689, 41444728, 41444743, 41444747, 41444752, 41444753, 41444758, 41444791, 41444797, 41444816, 41445001, 41445010, 41445014, 41445026, 41445032, 41445034, 41445070, 41445118, 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, 41445432, 41445434, 41445438, 41445448, 41445452, 41445495, 41445501, 41445502, 41445514, 41445515, 41445516, 41445538, 41445578, 41445582, 41445615, 41445616, 41445628, 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, 41446230, 41446262, 41446277, 41446290, 41446292, 41446323, 41446363, 41446377, 41446773, 41446796, 41446807, 41446808, 41455880, 41455885, 41455893, 41455894, 41455896, 41455897, 41455900, 41455902, 41455906, 41455910, 41455920, 41455924, 41455925, 41455932, 41455933, 41455944, 41455953, 41455955, 41586608, 41612034, 41622975, 41630856, 41660520, 41691748, 41747146, 41755552, 41765492, 41779600, 41779610, 41780160, 41780692, 41787786, 41792527, 41792800, 41792812, 41793290, 41793875, 41793888, 41795224, 41795344, 41796153, 41796154, 41851761, 41903418, 41903960, 41956849, 42028108, 42038023, 42046093, 42046440, 42046538, 42057324, 42057714, 42057739, 42063953, 42064058, 42066520, 42067824, 42067846, 42095488, 42172062, 42197144, 42206171, 42225697, 42288802, 42304719, 42313004, 42323439, 42365781, 42366186, 42371287, 42393465, 42393532, 42394072, 42394081, 42473102, 42478916, 42479274, 42508759, 42508767, 42552595, 42553772, 42564341, 42625859, 42635362, 42635423, 42635426, 42638228, 42638512, 42638525, 42639096, 42668010, 42735090, 42799507, 42799589, 42799745, 42802803, 42811500, 42812038, 42816302, 42823758, 42826856, 42826863, 42867879, 42878485, 42881036, 42881266, 42891020, 42891063, 42891095, 42891704, 42892018, 42892404, 42892430, 42892474, 42919054, 42919085, 42967816, 42985101, 42985218, 43043666, 43058934, 43067304, 43082276, 43084042, 43084220, 43084414, 43084803, 43119111, 43120325, 43151051, 43164789, 43165011, 43173591, 43179280, 43180544, 43209312, 43209348, 43209356, 43209360, 43230259, 43259235, 43263118, 43270340, 43305020, 43315510, 43320930, 43340698, 43392727, 43405811, 43420965, 43421081, 43433587, 43436747, 43438771, 43443622, 43443629, 43445198, 43446897, 43453558, 43453735, 43592438, 43594036, 43594037, 43613819, 43618965, 43622121, 43633429, 43633451, 43633473, 43633482, 43635004, 43646982, 43670742, 43682301, 43689832, 43704085, 43708891, 43709318, 43718660, 43719163, 43719245, 43720499, 43720519, 43720660, 43720677, 43720776, 43721160, 43721227, 43721256, 43721261, 43721670, 43721774, 43756720, 43848518, 43848783, 43848923, 43902667, 43914262, 43931289, 43931292, 43971849, 43973609, 43973613, 44004308, 44004309, 44015656, 44026775, 44028554, 44035662, 44038398, 44048852, 44065220, 44066424, 44203373, 44228355, 44235027, 44320671, 44328585, 44331478, 44339387, 44340251, 44388661, 44450326, 44524980, 44535485, 44536281, 44584972, 44604746, 44607889, 44616211, 44619593, 44619882, 44620455, 44621056, 44642682, 44643966, 44644567, 44649231, 44650811, 44654610, 44654626, 44654678, 44654764, 44654768, 44735751, 44743567, 44743568, 44830153, 44866223, 44879032, 44881204, 44891499, 44892275, 44892370, 45072647, 45103403, 45109943, 45168574, 45170504, 45170514, 45217802, 45310923, 45405221, 45409645, 45412976, 45414258, 45414330, 45422337, 45422339, 45426177, 45427575, 45427898, 45428128, 45428702, 45428705, 45428708, 45485899, 45509016, 45632472, 45632486, 47158877, 47158945, 47199780, 47199830, 47312619, 47357953, 47358023, 47374804, 47411367, 47420172, 47420433, 47420461, 47420472, 47420502, 47420508, 47420535, 47455986, 47553443, 47577223, 47590145, 47607770, 47622475, 47623407, 47702698, 47720792, 47721563, 47792300, 47799558, 47799928, 47838666, 48683576, 48967796, 48970231, 48991461, 49014958, 49015243, 49016170, 49016322, 49025922, 49027142, 49034146, 49035016, 49035916, 49036187, 49036189, 49036226, 49045867, 49100413, 49238037, 49296764, 49325440, 49346022, 49424887, 49433868, 49511310, 49511972, 49512071, 49520665, 49529173, 49530737, 49530808, 49531465, 49559821, 49598927, 49599004, 49599010, 49599013, 49599014, 49668232, 49680694, 49699073, 49710851, 49736903, 49747912, 49747961, 49750708, 49750757, 49750839, 49750856, 49753119, 49754349, 49755009, 49755457, 49902747, 49903433, 49960026, 49971619, 50030269, 50101555, 50116824, 50168449, 50176677, 50181736, 50186338, 50231447, 51332980, 51561052, 51827695, and 536596 / 520793.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Devices were distributed through out the US.
  • Description du dispositif
    Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

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