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Devices
Device Recall Easy Diagnost
Model / Serial
All systems with Eleva software version 4.x and stitching option.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
6 US customers
Product Description
Philips Easy Diagnost || Product Usage: Stationary Fluoroscopic system
Manufacturer
Philips Healthcare Inc.
1 Event
Recall of Device Recall Easy Diagnost
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Manufacturer
Philips Healthcare Inc.
Manufacturer Address
Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
Manufacturer Parent Company (2017)
Philips
Source
USFDA
3 devices with a similar name
Learn more about the data
here
Device Recall Easy Diagnost
Model / Serial
Site numbers 6961, 6962, 6963, 6964, 6965, 6966, 6967, 6968, 6969, 6970, 6971, 6972, 6973, 6974, 6975, 86401, 100727, 102386, 102553, 250068, 250410, 250828, 505640, X1072, X1075, X1135, X1218, X1297, X1302, X1401, X1708, X1750, X1770, X1771, 250302 6901, 6961, 6983, 6987, 10000, 10002, 10006, 10178, 10392, 10393, 10406, 10410, 10418, 10435, 10493, 13173, 13178, 13195, 13215, 13245, 13257, 13283, 13284, 13293, 13877, 13880, 13895, 13908, 13956, 13968, 13969, 13970, 13972, 13984, 13999, 14070, 14169, 14177, 26140, 26154, 26157, 26211, 26212, 26213, 26275, 38086, 38091, 38106, 38120, 38141, 38142, 38149, 38195, 38196, 38207, 38268, 38279, 38314, 38318, 38361, 38417, 38423, 38424, 38434, 38505, 38528, 38529, 38539, 38541, 38555, 38559, 38584, 38591, 38607, 38608, 38625, 38626, 38634, 38656, 38679, 38689, 38692, 38693, 38695, 38712, 38743, 38745, 38914, 38940, 38958, 38972, 38977, 38978, 38988, 40930, 40936, 40937, 40973, 41035, 41040, 41063, 41096, 41098, 41099, 41105, 41107, 41120, 41121, 41131, 41135, 41235, 41236, 41237, 41238, 41284, 41286, 41352, 41420, 41435, 41463, 41465, 41466, 41468, 44804, 44805, 44806, 44983, 45029, 45070, 45091, 45092, 50220, 50221, 50230, 50322, 50323, 50427, 50446, 50447, 52450, 52456, 52491, 59569, 59634, 59652, 59661, 59666, 62663, 62664, 62797, 62802, 62838, 62868, 62888, 62889, 62934, 62973, 62987, 62994, 62996, 62997, 73858, 76192, 76216, 76355, 76356, 76357, 76371, 76372, 76379, 76381, 76382, 76391, 76403, 76439, 76456, 76495, 76578, 76763, 76805, 76827, 76829, 76837, 76838, 76843, 76844, 76874, 76925, 76940, 76957, 76958, 76959, 76960, 76965, 76967, 76973, 76982, 80318, 80319, 80339, 82503, 82515, 82516, 82561, 82570, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82918, 82920, 82942, 82943, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83646, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84459, 84460, 84461, 84703, 84704, 84851, 84857, 84858, 84889, 84893, 84895, 84928, 84931, 84936, 84938, 84939, 84949, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85161, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85464, 85465, 85467, 85484, 85486, 85487, 85492, 85493, 85494, 85683, 86015, 86059, 86060, 86070, 86071, 86078, 86140, 86213, 86215, 86216, 86221, 86226, 86228, 86229, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86387, 86389, 86391, 86394, 86395, 86397, 86400, 86403, 86543, 86547, 86579, 86600, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86624, 86901, 86903, 86938, 86939, 86942, 86964, 86966, 86970, 86976, 86979, 86980, 87005, 87016, 87017, 87031, 87045, 87046, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87177, 87178, 87196, 87313, 87320, 87333, 87363, 87510, 87520, 87601, 87609, 87610, 100428, 100438, 100443, 100457, 100481, 100489, 100495, 100518, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100676, 100677, 100698, 100727, 100770, 100818, 100834, 100835, 100838, 100848, 100855, 100867, 100876, 100882, 100883, 100947, 100957, 101039, 101041, 101054, 101076, 101079, 101080, 101132, 101133, 101134, 101141, 101142, 101143, 101144, 101145, 101147, 101148, 101149, 101161, 101191, 101204, 101212, 101240, 101555, 101558, 101563, 101569, 101586, 101643, 101837, 101871, 101872, 101935, 101936, 101937, 101955, 101958, 101959, 101960, 102099, 102107, 102132, 102163, 102168, 102169, 102170, 102174, 102245, 102337, 102338, 102339, 102341, 102342, 102372, 102376, 102384, 102385, 102387, 102388, 102445, 102462, 102466, 102491, 102541, 102552, 102559, 102567, 102585, 102586, 102587, 102590, 102591, 102606, 102608, 102609, 102622, 102630, 102634, 102647, 102700, 102701, 102794, 102839, 102876, 102893, 102903, 102917, 102918, 102921, 102922, 102925, 103007, 103008, 103037, 103057, 103115, 103120, 103121, 103146, 103163, 103180, 103184, 103185, 103200, 103204, 103252, 103260, 103276, 103279, 103284, 103310, 103337, 103387, 103421, 103422, 103424, 103427, 103496, 103497, 103504, 103517, 103595, 103597, 103606, 103653, 103724, 103730, 103785, 103786, 103876, 103883, 103895, 103917, 103943, 103948, 103963, 103977, 104010, 104013, 104051, 104059, 104071, 104113, 104135, 104153, 104162, 104164, 104165, 104181, 104182, 104204, 104205, 104268, 104283, 104339, 104404, 104471, 104508, 104629, 104794, 104801, 104842, 104854, 104855, 104881, 104893, 104931, 105109, 105155, 105202, 105238, 105242, 105295, 105337, 105414, 105649, 105696, 105769, 250043, 250069, 250092, 250139, 250313, 250679, 500012, 504137, 504329, 504882, 505056, 505640, 506168, 506171, 519562, 519766, 519776, 519826, 520262, 520279, 520280, 521003, 530692, 532044, 534057, 534433, 534873, 535262, X1027, X1041, X1055, X1056, X1089, X1136, X1140, X1141, X1142, X1153, X1165, X1166, X1180, X1181, X1194, X1201, X1229, X1230, X1234, X1264, X1266, X1290, X1295, X1299, X1304, X1320, X1338, X1362, X1363, X1399, X1405, X1417, X1446, X1449, X1467, X1469, X1501, X1502, X1504, X1507, X1510, X1515, X1521, X1543, X1561, X1565, X1568, X1569, X1572, X1573, X1632, X1640, X1644, X1653, X1671, X1681, X1705, X1706, X1713, X1749, X1752, X1764, X1769 sites added - 6664, 38342, 76502, 103539, 103953, 103980, 105337, 105640, 250068, 250410, 504541, 504743, 505057, 506076, 506207, 506273, 520527, 521825, 530806, 543660, 543754, 545391, 546155, 546202, 546578, 547017, 547142, 553287, 557983, 557996, and 49794697.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
Product Description
Philips Easy Diagnost X-Ray System
Manufacturer
Philips Medical Systems North America Co. Phillips
Device Recall Easy Diagnost Eleva
Model / Serial
Site numbers 506647, 522015, 542061, 542308, 543275, 543426102549, 102551, 103130, 103515, 103522, 103523, 103666, 104078, 104614, 104812, 105482, 105589, 105678, 105775, 105777, 500003, 500032, 504642, 504643, 504803, 504804, 504879, 504941, 504962, 504966, 505062, 505063, 505104, 505255, 505349, 505539, 505540, 505606, 505806, 505871, 505926, 506117, 506199, 506205, 506208, 506210, 506231, 506233, 506248, 506249, 506250, 506251, 506275, 506276, 506277, 506278, 506281, 506305, 506554, 506828, 506844, 506845, 519117, 519121, 519122, 519128, 519152, 519773, 519879, 519900, 520182, 520183, 520209, 520300, 520301, 520516, 520707, 520798, 520806, 521135, 521153, 521606, 521654, 521658, 521869, 521942, 522015, 522193, 522271, 522399, 522401, 522443, 522470, 522480, 530573, 530607, 530795, 530797, 530798, 531769, 531832, 531857, 531860, 532069, 532107, 532137, 532139, 532157, 532170, 532174, 532177, 532360, 532397, 532398, 532426, 532471, 532477, 532479, 532766, 532779, 532842, 532971, 532978, 533234, 533240, 533243, 533313, 533389, 533396, 533451, 533470, 533490, 533491, 533528, 533558, 533562, 533565, 533566, 533574, 533766, 533770, 533771, 533867, 533898, 533914, 533918, 533968, 534207, 534419, 534434, 534596, 534599, 534600, 534615, 534644, 534647, 534675, 534677, 534694, 534782, 534803, 534805, 534815, 534822, 534824, 534850, 534867, 534945, 535021, 535233, 535255, 535365, 535378, 535382, 535436, 535437, 535500, 535613, 535757, 535765, 535771, 535785, 535908, 535995, 536011, 536051, 536081, 536082, 536179, 536200, 536394, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536914, 536933, 536938, 536941, 536973, 536984, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537654, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537967, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539411, 539419, 539488, 539501, 539519, 539527, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541075, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
Product Description
Philips Easy Diagnost Eleva
Manufacturer
Philips Medical Systems North America Co. Phillips
Device Recall Easy Diagnost Digital
Model / Serial
Site Numbers: 10392, 10393, 10493, 13173, 13178, 13195, 13215, 13283, 14177, 38195, 38196, 38361, 38679, 76979, 80318, 82571, 82613, 82630, 82646, 82675, 82712, 82722, 82831, 82943, 82949, 82954, 83031, 83074, 83083, 83308, 83370, 83646, 83648, 83651, 83909, 83936, 83944, 84420, 84434, 84459, 84460, 84461, 84858, 84893, 84895, 84931, 84939, 84963, 85109, 85117, 85147, 85148, 85161, 85166, 85167, 85168, 85184, 85402, 85405, 85437, 85438, 85464, 85467, 85484, 85486, 85487, 85683, 86015, 86071, 86078, 86213, 86215, 86216, 86226, 86228, 86309, 86344, 86358, 86359, 86384, 86386, 86387, 86394, 86397, 86547, 86606, 86618, 86903, 86964, 86990, 87005, 87016, 87017, 87045, 87046, 87050, 87051, 87136, 87137, 87138, 87142, 87177, 87196, 87363, 100426, 100438, 100489, 100495, 100518, 100555, 100604, 100618, 100727, 100770, 100876, 100882, 100883, 100957, 101039, 101132, 101133, 101134, 101141, 101142, 101144, 101148, 101579, 101586, 101587, 101886, 102168, 102169, 102170, 102172, 102173, 102337, 102338, 102339, 102340, 102341, 102342, 102372, 102384, 102387, 102462, 102463, 102466, 102541, 102552, 102559, 102585, 102586, 102590, 102591, 102782, 102783, 102818, 102839, 102918, 102921, 102922, 102925, 103115, 103120, 103146, 103158, 103204, 103260, 103457, 103504, 103595, 103653, 103657, 103713, 103730, 103785, 103786, 103876, 103892, 103895, 103943, 103977, 104013, 104040, 104059, 104071, 104162, 104164, 104205, 104339, 104346, 104365, 104466, 104508, 104674, 104850, 104851, 104854, 104855, 105769, 250092, 505340, 506718, 557792, 557794, 557796, 557797, 558019, 558063, 558170, 558174, 558184, 558224, 558285, 558300, 558310, 558366, 558370, and 41699603
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
Easy Diagnost Digital
Manufacturer
Philips Medical Systems North America Co. Phillips
Language
English
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