Devices

Device Recall EasyDiagnost Eleva xray systems

Model / Serial
FCO 70600034 and 70600035 Equipment #'s 102174, 102549, 102551, 103515, 103522, 103523, 104471, 104877, 105118, 105323, 105392, 105482, 105640, 105678, 105775, 105921, 105922, 105954, 504611, 504751, 504826, 504935, 504941, 505003, 505015, 505062, 505255, 505349, 505653, 505671, 505749, 505798, 505871, 506076, 506199, 506207, 506210, 506211, 506233, 506238, 506248, 506250, 506270, 506272, 506273, 506553, 506554, 506844, 506845, 519117, 519122, 519125, 519128, 519152, 519550, 519562, 519575, 519773, 519776, 519826, 519879, 519900, 520045, 520409, 520798, 521153, 521654, 521658, 521684, 521771, 521942, 522028, 522073, 522178, 522193, 522219, 522255, 522271, 522399, 522470, 522480, 530573, 530607, 530797, 530798, 530806, 531832, 532137, 532139, 532174, 532177, 532360, 532397, 532398, 532426, 532477, 532842, 532971, 533234, 533451, 533491, 533558, 533565, 533766, 533770, 533771, 533914, 533918, 534434, 534596, 534599, 534600, 534615, 534647, 534675, 534803, 534850, 534867, 535255, 535365, 535378, 535436, 535437, 535757, 535765, 535771, 535785, 536179, 536522, 536636, 536938, 536984, 536985, 537087, 537179, 537518, 537761, 537796, 537863, 538328, 538451, 538477, 538519, 538759, 538812, 538814, 539095, 539101, 539237, 539291, 539377, 539378, 539379, 539519, 539527, 539529, 539530, 539557, 539590, 540163, 540187, 540459, 540624, 540788, 541011, 541054, 541075, 541078, 541093, 541494, 541614, 541721, 541872, 542205, 542589, 542593, 542829, 542849, 543136, 543144, 543224, 543241, 543249, 543275, 543369, 543415, 543619, 543620, 543660, 543771, 543803, 544113, 544228, 544236, 544297, 544341, 544648, 544654, 545120, 545231, 545234, 545244, 545391, 545452, 545710, 545746, 545783, 545824, 545948, 545951, 546029, 546490, 547243, 547297, 547304, 547655, 547657, 547744, 547758, 547759, 547936, 547937, 548021, 548302, 548382, 548559, 548784, 549008, 549080, 549416, 550197, 550313, 550804, 550960, 551616, 551645, 551759, 551980, 552363, 552364, 552917, 552965, 552966, 553013, 553172, 553224, 553230, 553275, 553441, 553448, 553491, 553563, 554483, 554581, 554641, 554721, 554769, 555052, 555269, 555458, 555524, 556984, 557177, 557259, 557272, 558596, 41443633, 41443799, 41443813, 41443842, 41444437, 41444555, 41444600, 41444676, 41445431, 41445443, 41445458, 41445483, 41445650, 41445745, 41445752, 41445942, 41445982, 41445990, 41446006, 41446012, 41446214, 41446312, 41446777, 41487231, 41658234, 41658273, 41704405, 41862667, 41974615, 42029462, 42067090, 42122305, 42122745, 42162796, 42163516, 42225532, 42336983, 42379116, 42382599, 42456354, 42456355, 42617047, 42638020, 42823862, 42850557, 42880751, 42892412, 42892413, 43208952, 43452066, 43453550, 43613284, 43671121, 43680073, 43691433, 43708636, 43971738, 43989706, 44049065, 44065204, 44202885, 44340799, 44605123, 44621189, 44651312, and 4654127.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
EasyDiagnost Eleva x-ray systems
Manufacturer
Philips Medical Systems North America Co. Phillips
1 Event
- Recall of Device Recall EasyDiagnost Eleva xray systems

Manufacturer

Philips Medical Systems North America Co. Phillips

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

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