Philips Medical Systems North America Co. Phillips EasyDiagnost Eleva x-ray systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EasyDiagnost Eleva x-ray systems
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
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.
Products Sold
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.
Philips Medical Systems North America Co. Phillips is recalling EasyDiagnost Eleva x-ray systems due to Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
Recommended Action
Per FDA guidance
An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026