FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: EasyDiagnost Eleva x-ray systems
- Recall number
- Z-0353-2009
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- EasyDiagnost Eleva x-ray systems
- Status
- Terminated
- Initiated
- 2008-12-10
- Posted
- 2009-09-24
- Terminated
- 2012-08-17
- Reason
- Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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
- Quantity
- 332 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K031535"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28