Device Recall Allura XPER FD20

  • Model / Serial
    FCO 72200107, 72200112, and 72200117 for 1st phase 72200132 for 2nd phase  Equipment #'s 86914, 102166, 103282, 103380, 105294, 105670, 505876, 506539, 506540, 506778, 519195, 519894, 520319, 520491, 520598, 520630, 520631, 520632, 520660, 520755, 520779, 520783, 520814, 520948, 520977, 521001, 521154, 521222, 521311, 521312, 521314, 521315, 521512, 521548, 521589, 521659, 521675, 521820, 521890, 522397, 530368, 530391, 530392, 530485, 530584, 530663, 530664, 530666, 530715, 530783, 531728, 531752, 531760, 531762, 531808, 531817, 531830, 531834, 531931, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532077, 532150, 532207, 532225, 532227, 532239, 532244, 532245, 532249, 532262, 532263, 532264, 532294, 532532, 532533, 532649, 532990, 533084, 533284, 533285, 533287, 533325, 533395, 533398, 533543, 533551, 533738, 533763, 533772, 533857, 533897, 533955, 533956, 533966, 534108, 534131, 534150, 534152, 534158, 534215, 534217, 534232, 534246, 534250, 534255, 534269, 534270, 534374, 534380, 534418, 534420, 534431, 534452, 534545, 534565, 534569, 534639, 534646, 534665, 534682, 534716, 534720, 534724, 534730, 534787, 534796, 534798, 534810, 534811, 534856, 534927, 535094, 535151, 535152, 535173, 535213, 535274, 535278, 535285, 535303, 535367, 535376, 535396, 535418, 535424, 535439, 535492, 535566, 535611, 535615, 535635, 535702, 535727, 535772, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535982, 536006, 536007, 536014, 536030, 536067, 536136, 536154, 536155, 536163, 536173, 536174, 536178, 536234, 536433, 536471, 536592, 536641, 536646, 536714, 536717, 536736, 536796, 536798, 536801, 536901, 536921, 536954, 536993, 537024, 537073, 537118, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537590, 537597, 537604, 537717, 537743, 537784, 537805, 537810, 537838, 537854, 537922, 537934, 537938, 537985, 538102, 538193, 538194, 538228, 538234, 538322, 538369, 538386, 538404, 538406, 538449, 538464, 538465, 538466, 538479, 538482, 538512, 538538, 538771, 538813, 538902, 538910, 538911, 539094, 539204, 539220, 539267, 539268, 539322, 539323, 539369, 539380, 539381, 539398, 539456, 539472, 539479, 539634, 539745, 540048, 540082, 540150, 540167, 540203, 540209, 540213, 540275, 540284, 540288, 540312, 540321, 540325, 540338, 540374, 540421, 540456, 540460, 540487, 540622, 540684, 540721, 540790, 540808, 540887, 540912, 540930, 540952, 540973, 541030, 541046, 541047, 541049, 541053, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541509, 541572, 541659, 541715, 541742, 541748, 541783, 541848, 541873, 541880, 542306, 542382, 542478, 542486, 542518, 542522, 542526, 542744, 543087, 543213, 543216, 543229, 543386, 543397, 543398, 543399, 543444, 543611, 543759, 543762, 543799, 543850, 543877, 543931, 543971, 543972, 543984, 544005, 544052, 544057, 544086, 544103, 544120, 544130, 544184, 544371, 544489, 544513, 544550, 544581, 544631, 544636, 544655, 544728, 544729, 544750, 544989, 545024, 545073, 545090, 545262, 545280, 545282, 545293, 545295, 545521, 545539, 545640, 545714, 545733, 545749, 545750, 545752, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545905, 545912, 545921, 545941, 545964, 545975, 545985, 545991, 546014, 546025, 546060, 546201, 546456, 546517, 546585, 546586, 546634, 546668, 546679, 546693, 546886, 546908, 547005, 547058, 547118, 547234, 547287, 547334, 547364, 547392, 547601, 547619, 547620, 547621, 547627, 547628, 547700, 547720, 547729, 547748, 547753, 547770, 547775, 547777, 547795, 547800, 547822, 547833, 547838, 547852, 547855, 547861, 547893, 547896, 547898, 547918, 547921, 547925, 547932, 547948, 547952, 547976, 547977, 548022, 548029, 548039, 548049, 548051, 548054, 548061, 548108, 548192, 548496, 548601, 548616, 548640, 548660, 548764, 548775, 548778, 548785, 549170, 549245, 549250, 549252, 549253, 549264, 549306, 549378, 549379, 549385, 549750, 549902, 549925, 549967, 550031, 550053, 550122, 550133, 550173, 550244, 550253, 550304, 550371, 550399, 550404, 550451, 551050, 551051, 551146, 551178, 551340, 551370, 551607, 551608, 551725, 551763, 551851, 551853, 552178, 552192, 552202, 552279, 552381, 552382, 552425, 552440, 552469, 552546, 552590, 552736, 553097, 553288, 553330, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553723, 553798, 553803, 553846, 553867, 553868, 553869, 553871, 553873, 553881, 553984, 554008, 554018, 554044, 554049, 554054, 554136, 554370, 554447, 554518, 554680, 554731, 554763, 554775, 554776, 554784, 554811, 555300, 555321, 555343, 555349, 555350, 555420, 555447, 555461, 555470, 555588, 555742, 555927, 556017, 556095, 556156, 556203, 556323, 556389, 556390, 556470, 556601, 556605, 556609, 556701, 556709, 556760, 556810, 556811, 556814, 556820, 556855, 556857, 556893, 557653, 557808, 558238, 558448, 558499, 558582, 558831, 558832, 558949, 41416356, 41443671, 41443928, 41444385, 41444398, 41444603, 41444646, 41444743, 41444747, 41444758, 41444791, 41444797, 41445010, 41445014, 41445070, 41445169, 41445202, 41445207, 41445261, 41445285, 41445309, 41445310, 41445385, 41445438, 41445452, 41445495, 41445502, 41445516, 41445582, 41445640, 41445649, 41445692, 41445701, 41445785, 41445786, 41445809, 41445817, 41445875, 41445978, 41445989, 41446007, 41446039, 41446117, 41446217, 41446223, 41446277, 41446292, 41446323, 41446808, 41455893, 41455896, 41455900, 41455902, 41455910, 41455924, 41455955, 41691748, 41755552, 41787786, 41792800, 41792812, 41793875, 41796153, 41851761, 41956849, 42028108, 42038023, 42057714, 42067696, 42095488, 42172062, 42197144, 42206171, 42288802, 42313004, 42365781, 42366186, 42552595, 42638525, 42668010, 42826856, 42826863, 42985101, and 43082872.  Additional Equipment #s for Phase 2 - 10440, 10441, 14145, 38358, 38925, 41272, 50438, 76378, 80320, 82537, 84721, 86066, 86290, 86989, 100503, 100683, 100708, 100713, 100948, 101139, 101606, 101607, 101966, 102563, 102776, 103144, 103231, 103287, 103957, 104056, 104077, 504315, 546465, 555781, 557790, 557809, 557841, 557956, 558199, 560060, 36190293, 41443700, 41443707, 41443774, 41443855, 41444399, 41444446, 41444463, 41444558, 41444597, 41444753, 41445026, 41445119, 41445125, 41445233, 41445246, 41445254, 41445255, 41445256, 41445315, 41445336, 41445427, 41445434, 41445486, 41445578, 41445616, 41445676, 41445804, 41445916, 41446044, 41446150, 41446211, 41446363, 41446796, 41586608, 41630856, 41765492, 41779600, 41779610, 41792527, 42046538, 42063953, 42066520, 42225697, 42323439, 42394081, 42473102, 42478916, 42635362, 42635423, 42635426, 42638228, 42638512, 42811500, 42812038, 42823758, 42878485, 42878591, 42881036, 42881266, 42892018, 42892430, 42892474, 42919054, 42919085, 42967816, 42985218, 43082276, 43084042, 43084414, 43119111, 43120325, 43165011, 43180544, 43209312, 43209348, 43209356, 43230259, 43263118, 43320930, 43340698, 43392727, 43420965, 43421081, 43433587, 43438771, 43443629, 43445198, 43592438, 43594036, 43594037, 43613819, 43618965, 43622121, 43704085, 43708891, 43720519, 43720677, 43720776, 43721160, 43721256, 43848518, 43914262, 43971849, 43973609, 43973613, 44004308, 44004309, 44015656, 44038398, 44203373, 44642682, 44891499, 47455986, and 49408181.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Allura XPER FD20
  • Manufacturer
  • 1 Event

Manufacturer

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

11 devices with a similar name

Learn more about the data here

  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Allura Xper FD20/10; Model Numbers: 722029 || Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
  • Manufacturer
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Allura Xper FD20/15; Model Numbers: 722058 || Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
  • Manufacturer
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Allura Xper FD20; Model Numbers: 722028 722012 722006 || Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
  • Manufacturer
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Allura Xper FD20 OR Table; Model Numbers: 722035 722023 || Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
  • Manufacturer
  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 || Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
  • Manufacturer
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