一覧へ戻る

平成19年9月6日作成

医療機器改修の概要

(クラスII)



  1. 一般名及び販売名

      (1) 一般的名称:汎用超音波画像診断装置
        販 売 名:超音波診断装置 NEMIO SSA−550A
    
      (2) 一般的名称:汎用超音波画像診断装置
        販 売 名:超音波診断装置 Nemio XG SSA−580A
    
    
  2. 対象ロット、数量及び出荷時期

     (1)型式名    :SSA-550A
        製造番号   :O5542113, O5542115, O5542116, O5542117, O5542118
               O5542119, O5542120, O5542121, O5542147, O5542148
               O5542149, O5542182, O5542183, O5542184, O5542185
               O5542186, O5542187, O5542188, O5542189, O5542190
               O5542191, O5542192, O5542193, O5542194, O5542195
               O5542197, O5542198, O5542199, O5542200, O5542201
               O5542202, O5542203, O5542204, O5542205, O5542206
               O5542207, O5542239, O5542240, O5542241, O5542242
               O5542243, O5542244, O5542245, O5542247, O5542296
               O5542297, O5542298, O5542299, O5542300, O5542301
               O5542302, O5542303, O5542304, O5542305, O5542306
               O5542307, O5552326, O5552327, O5552328, O5552329
               O5552331, O5552332, O5552333, O5552370, O5552371
               O5552373, O5552374, O5552375, O5552377, O5552378
               O5552379, O5552380, O5552381, O5552382, O5552403
               O5552404, O5552405, O5552406, O5552408, O5552409
               O5552410, O5552411, O5552412, O5552413, O5552414
               O5552415, O5552416, O5552417, O5552418, O5552419
               O5552420, O5552421, O5552422, O5552423, O5552424
               O5552425, O5552426, O5552457, O5552458, O5552459
               O5552460, O5552461, O5552462, O5552463, O5552464
               O5552465, O5552466, O5552467, O5552468, O5552469
               O5552470, O5552471, O5552472, O5552473, O5552474
               O5552476, O5552477, O5552478, O5552479, O5552480
               O5552481, O5552482, O5552483, O5552486, O5552487
               O5552488, O5552489, O5552490, O5552508, O5552509
               O5552510, O5552511, O5552512, O5562574, O5562575
               O5562576, O5562578, O5562579, O5562580, O5562581
               O5562582, O5562583, O5562584, O5562585, O5562586
               O5562587, O5562588, O5562590, O5562617, O5562618
               O5562619, O5562620, O5562621, O5562622, O5562623
               O5562624, O5562627, O5562628, O5562629, O5562630
               O5562631, O5562632, O5562633, O5562634, O5562637
               O5562638, O5562640, O5562641, O5562642, O5562643
               O5562644, O5562645, O5562647, O5562648, O5562649
               O5562650, O5562651, O5562652, O5562653, O5562654
               O5562655, O5562656, O5562657, O5562658, O5562659
               O5562660, O5562661, O5562687, O5562688, O5562689
               O5562690, O5562691, O5562692, O5562694, O5562695
               O5562696, O5562697, O5562698, O5562699, O5562700
               O5562701, O5562705, O5562706, O5562707, O5562708
               O5562709, O5562710, O5562711, O5562712, O5562713
               O5562716, O5562717, O5562719, O5562779, O5562780
               O5562790, O5562791, O5562792, O5562794, O5562795
               O5562796, O5562798, O5562799, O5572818, O5572819
               O5572820, O5572821, O5572823, O5572824, O5572825
               O5572826, O5572827, O5572828, O5572829, O5572830
               O5572831, O5572832, O5572834, O5572835, O5572836
               O5572900, O5572901, O5572902, O5572904, O5572905
               O5572906, O5572907, O5572908, O5572909, O5572910
               O5572911, O5572912, O5572913, O5572914, O5572915
               O5572916, O5572917, O5572918, O5572926, O5572927
               O5572928, O5572929, O5572930, O5572931, O5572933
               O5572934, O5572935, O5572936, O5572937, O5572938
               O5572939, O5573024, O5573025, O5573026, O5573027
               O5573028, O5573029, O5573031, O5573032, O5573034
               O5573035, P5573041, P5573042, P5573043, P5573044
               P5573045, P5573046, P5573047, P5573048, P5573049
               P5573050, P5573051, P5573053, P5573095, P5573116
               P5573117, P5573118, P5573119, P5573121, P5573122
               P5573123, P5573124, P5573125, P5573126, P5573127
               P5573128, P5573184, P5573185, P5573186, P5573187
               P5573188, P5573189, P5573205, P5573206, P5573207
               P5573208, P5573209, P5573210, P5573211, P5573216
               P5573217, P5573218, P5573219, P5573220, P5573221
               P5573222, P5573223, P5573224, P5573242, P5573243
               P5573244, P5573245, P5573250, P5573251, P5573260
               P5573261, P5583268, P5583269, P5583270, P5583271
               P5583272, P5583273, P5583274, P5583275, P5583276
               P5583277, P5583278, P5583279, P5583280, P5583281
               P5583282, P5583283, P5583286, P5583287, P5583345
               P5583346, P5583347, P5583348, P5583349, P5583350
               P5583351, P5583352, P5583353, P5583354, P5583355
               P5583356, P5583357, P5583358, P5583359, P5583360
               P5583361, P5583362, P5583363, P5583364, P5583365
               P5583371, P5583372, P5583373, P5583374, P5583375
               P5583376, P5583377, P5583378, P5583379, P5583380
               P5583381, P5583382, P5583383, P5583384, P5583385
               P5583386, P5583387, P5583388, P5583389, P5583390
               P5583391, P5583392, P5583393, P5583394, P5583395
               P5583396, P5583397, P5583434, P5583435, P5583436
               P5583437, P5583438, P5583439, P5583440, P5583441
               P5583442, P5583443, P5583444, P5583445, P5583446
               P5583447, P5583448, P5583449, P5583451, P5583452
               P5583453, P5583454, P5583455, P5583456, P5583457
               P5583459, P5583461, P5583462, P5583463, P5583464
               P5583465, P5583466, P5583468, P5583469, P5583471
               P5583472, P5583473, P5583474, P5583498, P5583499
               P5583500, P5583501, P5583502, P5583503, P5583504
               P5583505, P5583506, P5583508, P5583509, P5583510
               P5583511, P5583512, P5583513, P5583514, P5583515
               P5583516, P5583517, P5583518, P5583519, P5583520
               P5583521, P5583522, P5583523, P5583524, P5583525
               P5583526, P5583527, P5583530, P5583531, P5583532
               P5583533, P5583535, P5583536, P5583537, P5583538
               P5583540, P5583541, P5583596, P5583597, P5583598
               P5583599, P5583601, P5583602, P5583603, P5583605
               P5583606, P5583607, P5583608, P5583609, P5583610
               P5583611, P5583612, P5583613, P5583614, P5593618
               P5593619, P5593620, P5593621, P5593622, P5593623
               P5593624, P5593625, P5593626, P5593627, P5593673
               P5593675, P5593677, P5593678, P5593679, P5593680
               P5593681, P5593682, P5593683, P5593722, P5593723
               P5593724, P5593725, P5593726, P5593728, P5593729
               P5593730, P5593731, P5593732, P5593733, P5593734
               P5593735, P5593736, P5593737, P5593738, P5593739
               P5593740, P5593741, P5593742, P5593743, P5593744
               P5593745, P5593746, P5593747, P5593748, P5593749
               P5593750, P5593751, P5593752, P5593753, P5593760
               P5593761, P5593762, P5593766, P5593767, P5593768
               P5593769, P5593770, P5593771, P5593772, P5593773
               P5593774, P5593775, P5593776, P5593777, P5593778
               P5593779, P5593780, P5593781, P5593782, P5593783
               P5593784, P5593802, P5593803, P5593805, P5593807
               P5593808, P5593809, P5593810, P5593811, P5593812
               P5593813, P5593815, P5593816, P5593817, P5593818
               P5593819, P5593820, P5593821, P5593822, P5593823
               P5593824, P5593825, P5593826, P5593827, P5593828
               P5593829, P5593830, P5593831, P5593832, P5593833
               P5593834, P5593835, P5593836, P5593837, P5593838
               P5593839, P5593840, P5593841, P5593842, P5593843
               P5593844, P5593845, P5593846, P5593847, P5603857
               P5603858, P5603921, P5603922, P5603923, P5603932
               P5603933, P5603934, P5603935, P5603936, P5603937
               P5603938, P5603939, P5603940, P5603941, P5603942
               P5603943, P5603944, P5603947, P5603948, P5603949
               P5603950, P5604041, P5604042, P5604043, P5604044
               P5604045, P5604046, P5604047, P5604048, P5604049
               P5604050, P5604051, P5604052, P5604053, P5604054
               P5604055, P5604056, P5604057, P5604058, P5604064
               P5604065, P5604066, P5604067, P5604068, P5604069
               P5604070, P5604071, P5604072, P5604073, P5604074
               P5604121, P5604122, P5604123, P5604124, P5604125
               P5604126, P5604127, P5604128, P5604129, P5604130
               P5604131, P5604132, P5604154, P5604155, P5604156
               P5604157, P5604158, P5604159, P5604160, P5604161
               P5604162, P5604164, P5604165, P5604166, P5604167
               P5604168, P5604169, P5604192, P5604193, P5604194
               P5604195, P5604197, P5604198, P5604199, P5604200
               P5604201, P5604202, P5604203, P5604204, P5604208
               P5604209, P5614262, P5614263, P5614264, P5614265
               P5614266, P5614267, P5614403, P5614404, P5614405
               P5614406, P5614407, P5614408, P5614409, P5614410
               P5614411, P5614412, P5614435, P5614436, P5614437
               P5614438, P5614439, P5614482, P5614483, P5614484
               P5614485, P5614486, P5614487, P5614488, P5614489
               P5614490, P5614516, P5614517, P5614518, P5614519
               P5624575, P5624576, P5624577, P5624578, P5624579
               P5624580, P5624581, P5624587, P5624588, P5624589
               P5624590, P5624591, P5624592, P5624666, P5624667
               P5624668, P5624669, P5624670, P5624671, P5624672
               P5624674, P5624675, P5624676, P5624677, P5624678
               P5624679, P5624680, P5624694, P5624695, P5624697
               P5624698, P5624701, P5624702, P5624703, P5624704
               P5624705, P5624706, P5624707, P5624708, P5624710
               P5624711, P5624712, P5624755, P5624756, P5624757
               P5624758, P5624759, P5624760, P5624761, P5624763
               P5624764, P5624765, P5624766, P5624767, P5624768
               P5624769, P5624770, P5624771, P5624772, P5624773
               P5624774, P5624775, P5624776, P5624777, P5624778
               P5624779, P5624780, P5624781, P5624786, P5624787
               P5624788, P5624790, P5624791, P5624792, P5624793
               P5624794, P5624795, P5624797, P5624798, P5624799
               P5624800, P5624801, P5624802, P5624803, P5624804
               P5624805, P5624848, P5624849, P5624850, P5624851
               P5624852, P5624853, P5624854, P5624855, P5624857
               P5624858, P5624859, P5624860, P5624869, P5624870
               P5624871, P5624872, P5624873, P5624874, P5624875
               P5624876, P5624878, P5624879, P5624880, P5624881
               P5624882, P6514905, P6514906, P6514907, P6514908
               P6514909, P6514910, P6514912, P6514914, P6514915
               P6514916, P6514917, P6514918, P6514921, P6514986
               P6514987, P6514988, P6514989, P6514990, P6514991
               P6514992, P6514993, P6514994, P6514995, P6514996
               P6514997, P6514998, P6515001, P6515002, P6515003
               P6515004, P6515006, P6515007, P6515025, P6515026
               P6515027, P6515028, P6515029, P6515030, P6515031
               P6515032, P6515079, P6515080, P6515081, P6515082
               P6515083, P6515084, P6515085, P6515086, P6515127
               P6515128, P6515129, P6515130, P6515187, P6515188
               P6515189, P6515191, P6515192, P6515193, P6515194
               P6515195, P6515196, P6515197, P6515214, P6515215
               P6515216, P6515217, P6515218, P6515219, P6515220
               P6515221, P6515222, P6515223, P6515224, P6525274
               P6525275, P6525276, P6525277, P6525278, P6525279
               P6525280, P6525329, P6525330, P6525331, P6525332
               P6525333, P6525349, P6525350, P6525351, P6525352
               P6525354, P6525355, P6525356, P6525357, P6525358
               P6525359, P6525360, P6525361, P6525362, P6525364
               P6525365, P6525366, P6525367, P6525368, P6525369
               P6525370, P6525371, P6525372, P6525436, P6525437
               P6525451, P6525452, P6525453, P6525454, P6525455
               P6525456, P6525457, P6525458, P6525459, P6525460
               P6525461, P6525463, P6525464, P6525465, P6525520
               P6525521, P6525522, P6525523, P6525524, P6525525
               P6525526, P6525527, P6525528, P6525529, P6525530
               P6525531, P6525532, P6525533, P6525534, P6525535
               P6525536, P6525537, P6525538, P6525539, P6525540
               P6525541, P6525542, P6525543, P6525544, P6525545
               P6525546, P6525547, P6525548, P6525549, P6525550
               P6525551, P6525552, P6525553, P6525556, P6525557
               P6525558, P6525560, P6525561, P6525562, P6525586
               P6525587, P6525588, P6525589, P6525590, P6525591
               P6525592, P6525593, P6525594, P6525595, P6525596
               P6525597, P6525598, P6525599, P6525600, P6525609
               P6525610, P6525621, P6525623, P6525624, P6525626
               P6525627, P6535669, P6535670, P6535671, P6535672
               P6535673, P6535674, P6535675, P6535676, P6535677
               P6535678, P6535679, P6535680, P6535681, P6535682
               P6535683, P6535684, P6535685, P6535686, P6535687
               P6535688, P6535689, P6535690, P6535691, P6535692
               P6535693, P6535694, P6535695, P6535698, P6535699
               P6535700, P6535701, P6535720, P6535721, P6535722
               P6535723, P6535724, P6535725, P6535726, P6535727
               P6535728, P6535729, P6535730, P6535731, P6535732
               P6535734, P6535735, P6535737, P6535738, P6535739
               P6535740, P6535741, P6535742, P6535743, P6535744
               P6535745, P6535746, P6535747, P6535748, P6535749
               P6535750, P6535751, P6535752, P6535753, P6535754
               P6535755, P6535756, P6535757, P6535758, P6535759
               P6535760, P6535761, P6535762, P6535763, P6535764
               P6535765, P6535766, P6535767, P6535768, P6535769
               P6535770, P6535771, P6535772, P6535773, P6535774
               P6535776, P6535777, P6535778, P6535779, P6535780
               P6535781, P6535782, P6535783, P6535784, P6535785
               P6535786, P6535792, P6535793, P6535794, P6535795
               P6535796, P6535797, P6535798, P6535799, P6535800
               P6535801, P6535802, P6535803, P6535804, P6535805
               P6535806, P6535807, P6535808, P6535809, P6535810
               P6535811, P6535812, P6535813, P6535814, P6535815
               P6535816, P6535817, P6535818, P6535821, P6535822
               P6535823, P6535824, P6535826, P6535827, P6535828
               P6535829, P6535830, P6535831, P6535832, P6535833
               P6535834, P6535836, P6535838, P6535839, P6535840
               P6545841, P6545842, P6545843, P6545844, P6545845
               P6545846, P6545847, P6545848, P6545849, P6545850
               P6545851, P6545852, P6545853, P6545923, P6545924
               P6545925, P6545926, P6545927, P6545935, P6545936
               P6545940, P6545941, P6545942, P6545943, P6545944
               P6545945, P6545946, P6545947, P6545948, P6545949
               P6545990, P6545991, P6545992, P6545993, P6545994
               P6545995, P6545996, P6545997, P6545998, P6545999
               P6546000, P6546002, P6546003, P6546004, P6546007
               P6546008, P6546009, P6546010, P6546011, P6546012
               P6546013, P6546014, P6546015, P6546016, P6546017
               P6546018, P6546020, P6546023, P6546024, P6546025
               P6546026, P6546027, P6546028, P6546053, P6546054
               P6546055, P6546057, P6546058, P6546059, P6546060
               P6546061, P6546062, P6546063, P6546065, P6546066
               P6546067, P6546068, P6546069, P6546070, P6546071
               P6546072, P6546084, P6546085, P6546086, P6546088
               P6546089, P6546090, P6546091, P6546092, P6546093
               P6546094, P6546095, P6546096, P6546098, P6546099
               P6546100, P6546101, P6546102, P6546103, P6546104
               P6546105, P6546148, P6546149, P6546150, P6546152
               P6556155, P6556156, P6556157, P6556169, P6556170
               P6556171, P6556172, P6556173, P6556174, P6556175
               P6556176, P6556177, P6556201, P6556202, P6556203
               P6556204, P6556205, P6556206, P6556207, P6556208
               P6556209, P6556210, P6556211, P6556212, P6556213
               P6556214, P6556215, P6556216, P6556234, P6556235
               P6556236, P6556237, P6556240, P6556241, P6556242
               P6556243, P6556244, P6556245, P6556246, P6556247
               P6556249, P6556250, P6556251, P6556283, P6556284
               P6556285, P6556287, P6556288, P6556289, P6556290
               P6566291, P6566292, P6566293, P6566294, P6566295
               P6566323, P6566332, P6566333, P6566334, P6566335
               P6566364, P6566365, P6566366, P6566367, P6566368
               P6566369, P6566370, P6566371, P6566372, P6566373
               P6566374, P6566375, P6566376, P6566378, P6566379
               P6566380, P6566381, P6566382, P6566383, P6566384
               P6566385, P6566386, P6566387, P6566388, P6566389
               P6566390, P6566391, P6566392, P6566393, P6566394
               P6566395, P6566396, P6566397, P6566410, P6566411
               P6566412, P6566413, P6566414, P6566415, P6566416
               P6566417, P6566418, P6566419, P6566420, P6566421
               P6566422, P6566431, P6566432, P6566433, P6566434
               P6566435, P6566471, P6566472, P6566473, P6566474
               P6566475, P6566476, P6566477, P6566478, P6566479
               P6566480, P6566483, P6576501, P6576502, P6576503
               P6576504, P6576505, P6576507, P6576508, P6576509
               P6576510, P6576513, P6576514, P6576515, P6576516
               P6576517, P6576518, P6576519, P6576520, P6576525
               P6576526, P6576527, P6576528, P6576529, P6576530
               P6576531, P6576532, P6576533, P6576534, P6576535
               P6576536, P6576539, P6576540, P6576541, P6576542
               P6576543, P6576544, P6576545, P6576546, P6576547
               P6576548, P6576549, P6576550, P6576551, P6576566
               P6576567, P6576568, P6576569, P6576570, P6576571
               P6576572, P6576573, P6576574, P6576575, P6576576
               P6576577, P6576578, P6576579, P6576580, P6576581
               P6576582, P6576583, P6576584, P6576585, P6576586
               P6576587, P6576588, P6576589, P6576590, P6576594
               P6576595, P6576596, P6576597, P6576598, P6576599
               P6576600, P6576601, P6576602, P6586611, P6586612
               P6586613, P6586614, P6586615, P6586616, P6586617
               P6586618, P6586619, P6586620, P6586642, P6586643
               P6586644, P6586645, P6586646, P6586647, P6586648
               P6586649, P6586650, P6586651, P6586653, P6586654
               P6586655, P6586656, P6586657, P6586658, P6586659
               P6586660, P6586661, P6586688, P6586689, P6586690
               P6586691, P6586692, P6586695, P6586696, P6586697
               P6586698, P6586699, P6586700, P6586701, P6586702
               P6586703, P6586704, P6586705, P6586706, P6586707
               P6586708, P6586709, P6586710, P6586711, P6586712
               P6586713, P6586714, P6586722, P6586723, P6586724
               P6586725, P6586726, P6586727, P6586728, P6586729
               P6586730, P6586731, P6586732, P6586733, P6586734
               P6586735, P6586736, P6586737, P6586738, P6586739
               P6586740, P6586741, P6586743, P6586744, P6586745
               P6586746, P6586747, P6586750, P6586751, P6586752
               P6586753, P6586754, P6586755, P6586788, P6586789
               P6586792, P6586793, P6586794, P6596830, P6596831
               P6596832, P6596833, P6596834, P6596835, P6596836
               P6596837, P6596838, P6596839, P6596840, P6596841
               P6596842, P6596843, P6596845, P6596847, P6596848
               P6596849, P6596850, P6596851, P6596852, P6596853
               P6596854, P6596855, P6596856, P6596857, P6596858
               P6596859, P6596860, P6596861, P6596862, P6596863
               P6596864, P6596865, P6596866, P6596867, P6596868
               P6596869, P6596870, P6596871, P6596872, P6596873
               P6596874, P6596875, P6596876, P6596877, P6596878
               P6596890, P6596891, P6596892, P6596893, P6596894
               P6596895, P6596896, P6596897, P6596898, P6596899
               P6596900, P6596901, P6596902, P6596903, P6596904
               P6596911, P6596918, P6596919, P6596920, P6596921
               P6596923, P6596924, P6596925, P6596938, P6596939
               P6596940, P6596941, P6596942, P6596943, P6596945
               P6596946, P6596947, P6596948, P6596949, P6596950
               P6596952, P6596953, P6596956, P6596957, P6596959
               P6596960, P6596961, P6596962, P6596963, P6596964
               P6596965, P6596966, P6596967, P6596968, P6596969
               P6596970, P6596971, P6596972, P6596973, P6596974
               P6596975, P6596976, P6596977, P6596978, P6602003
               P6602004, P6602005, P6602007, P6602008, P6602009
               P6602014, P6602015, P6602016, P6602017, P6602019
               P6602020, P6602061, P6602062, P6602063, P6602064
               P6602065, P6602066, P6602067, P6602068, P6602071
               P6602072, P6602103, P6602104, P6602105, P6602106
               P6602107, P6602108, P6602109, P6602110, P6602111
               P6602113, P6602114, P6602121, P6602122, P6602123
               P6602124, P6602125, P6602126, P6602127, P6602128
               P6602129, P6602130, P6602149, P6602150, P6602151
               P6602152, P6602153, P6602154, P6602155, P6602156
               P6602157, P6602158, P6602159, P6602160, P6602164
               P6612350, P6622360, P6622361, P6622362, P6622363
               P6622364, P6622365, P6622403, P6622404, P6622406
               P6622407, P6622408, P6622409, P6622491, P6622492
               P6622494, P6622495, P6622497, P6622498, P6622499
               P6622556, P6622557, P6622558, P6622559, P6622560
               P6622561, P6622562, P6622563, P6622564, P6622565
               P6622566, P6622567, P6622568, P6622570, P6622571
               P6622572, P6622574, P6622575, P6622576, P7512600
               P7512601, P7512630, P7512631, P7512632, P7512634
               P7512635, P7512636, P7512637, P7512638, P7512719
               P7512720, P7512721, P7512722, P7512723, P7512729
               P7512731, P7512732, P7512733, P7512734, P7512735
               P7512736, P7512769, P7512770, P7512773, P7512774
               P7512775, P7512776, P7512777, P7512778, P7512779
               P7512780, P7512781, P7512782, P7512783, P7512784
               P7512793, P7512794, P7512795, P7512796, P7512797
               P7512798, P7512799, P7522825, P7522826, P7522827
               P7522828, P7522829, P7522830, P7522870, P7522871
               P7522872, P7522873, P7522874, P7522875, P7522876
               P7522877, P7522878, P7522880, P7522881, P7522882
               P7522883, P7522884, P7522885, P7522901, P7522902
               P7522903, P7522904, P7522905, P7522906, P7522946
               P7522947, P7522948, P7522949, P7522950, P7522962
               P7522963, P7522964, P7522965, P7522966, P7522967
               P7522968, P7522969, P7522970, P7522971, P7522972
               P7522973, P7522974, P7523030, P7523031, P7523032
               P7523033, P7523035, P7523036, P7523037, P7523038
               P7523039, P7523040, P7523041, P7523042, P7523043
               P7523044, P7523045, P7523046, P7523057, P7523058
               P7533060, P7533061, P7533070, P7533072, P7533081
               P7533082, P7533083, P7533084, P7533085, P7533086
               P7533087, P7533091, P7533097, P7533098, P7533099
               P7533101, P7533103, P7533104, P7533105, P7533106
               P7533107, P7533108, P7533109, P7533110, P7533111
               P7533128, P7533129, P7533131, P7533132, P7533151
               P7533152, P7533153, P7533155, P7533156, P7533157
               P7533158, P7533159, P7533160, P7533161, P7533162
               P7533163, P7533164, P7533165, P7533166, P7533167
               P7533168, P7533169, P7533170, P7533171, P7533172
               P7533173, P7533174, P7533175, P7533176, P7533177
               P7533212, P7533213, P7533214, P7533217, P7533243
               P7533244, P7533245, P7533246, P7533247, P7533248
               P7533249, P7533250, P7533263, P7533264, P7543265
               P7543309, P7543353, P7543371, P7543385, P7543388
               P7543390, P7543391, P7543392, P7543394
    
        出荷数量  :1949台
        出荷時期  :平成 17 年 4 月〜平成 19 年 5 月
    
     (2) 型式名    :SSA-580A
        製造番号  :C1A0642086, C1A0642087, C1A0642088, C1A0642089, C1A0642090
               C1A0642091, C1A0642092, C1A0642094, C1A0642095, C1A0642096
               C1A0642097, C1A0642098, C1A0642099, C1A0652116, C1A0652117
               C1A0652118, C1B0662259, C1B0662260, C1B0662261, C1B0662262
               C1B0662263, C1B0662264, C1B0662265, C1B0662266, C1B0662267
               C1B0662268, C1B0662307, C1B0662308, C1B0662309, C1B0662310
               C1B0662311, C1B0662312, C1B0662313, C1B0662314, C1B0662315
               C1B0662316, C1B0662317, C1B0662318, C1B0662319, C1B0662320
               C1B0662321, C1B0662332, C1B0662333, C1B0662334, C1B0662335
               C1B0662336, C1B0662338, C1B0662339, C1B0662340, C1B0662341
               C1B0662342, C1B0662343, C1B0662344, C1B0662345, C1B0662346
               C1B0672388, C1B0672389, C1B0672390, C1B0672423, C1B0672424
               C1B0672425, C1B0672426, C1B0672427, C1B0672428, C1B0672429
               C1B0672430, C1B0672431, C1B0672432, C1B0672471, C1B0672497
               C1B0672498, C1B0672499, C1B0672500, C1B0672501, C1B0672502
               C1B0672503, C1B0672504, C1B0672505, C1B0672506, C1B0672507
               C1B0672508, C1B0672509, C1B0672510, C1B0672511, C1B0672512
               C1B0672513, C1B0672514, C1B0672515, C1B0672516, C1B0672517
               C1B0672518, C1B0682602, C1B0682603, C1B0682604, C1B0682605
               C1B0682642, C1B0682643, C1B0682644, C1B0682645, C1B0682646
               C1B0682647, C1B0682649, C1B0682650, C1B0682651, C1B0682652
               C1B0682653, C1B0682654, C1B0682655, C1B0682656, C1B0682657
               C1B0692761, C1B0692762, C1B0692763, C1B06X2780, C1B06X2781
               C1B06X2782, C1B06X2783, C1B06X2821, C1B06X2822, C1B06X2823
               C1B06X2824, C1C06Y2987, C1C06Z3045, C1C06Z3046, C1C06Z3047
               C1C06Z3048, C1C06Z3049, C1C06Z3073, C1C06Z3074, C1C06Z3076
               C1C06Z3077, C1C06Z3078, C1C06Z3079, C1C06Z3080, C1C06Z3117
               C1C06Z3118, C1C06Z3119, C1C06Z3156, C1C06Z3157, C1C06Z3158
               C1C06Z3200, C1C06Z3201, C1C06Z3202, C1C06Z3203, C1C06Z3206
               C1C0713401, C1C0713403, C1C0713404, C1C0713405, C1C0713407
               C1C0713408, C1C0713409, C1C0713410, C1C0713411, C1C0713412
               C1C0713413, C1C0713414, C1C0713415, C1C0713416, C1C0713417
               C1C0723421, C1C0723470, C1C0723472, C1C0723473, C1C0723474
               C1C0723475, C1C0723476, C1C0723477, C1C0723478, C1C0723479
               C1C0723480, C1C0723481, C1C0723482, C1C0723483, C1C0733565
               C1C0733566, C1C0733582, C1C0733583, C1C0733584, C1C0733585
               C1C0733586, C1C0733587, C1C0733588, C1C0733589, C1C0733590
               C1C0733591, C1C0733592, C1C0733593, C1C0733594, C1C0733595
               C1C0733596, C1C0733597, C1C0733616, C1C0733617, C1C0733618
               C1C0733619, C1C0733621, C1C0733622, C1C0733623, C1C0733624
               C1C0733625, C1C0733626, C1C0733627, C1C0733629, C1C0733630
               C1C0733631, C1C0733632, C1C0733633, C1C0733634, C1C0733635
               C1C0733636, C1C0733637, C1C0733639, C1C0733640, C1C0733641
               C1C0733642, C1C0733742, C1C0733743, C1C0743779, C3B0662231
               C3B0662233, C3B0662234, C3B0662235, C3B0662236, C3B0662237
               C3B0662238, C3B0662240, C3B0662241, C3B0662242, C3B0662243
               C3B0662244, C3B0662245, C3B0662246, C3B0662247, C3B0662294
               C3B0662295, C3B0662296, C3B0662297, C3B0662298, C3B0662299
               C3B0662301, C3B0672455, C3B0672457, C3B0672458, C3B0672459
               C3B0672460, C3B0672461, C3B0672462, C3B0672463, C3B0672464
               C3B0672465, C3B0672479, C3B0672480, C3B0672481, C3B0672564
               C3B0672565, C3B0672566, C3B0672567, C3B0672568, C3B0672569
               C3B0672570, C3B0672571, C3B0672572, C3B0672573, C3B0682587
               C3B0682588, C3B0682589, C3B0682590, C3B0682591, C3B0682592
               C3B0682593, C3B0682696, C3B0682697, C3B0682698, C3B0682699
               C3B0682700, C3B0682701, C3B0682703, C3B0682726, C3B0682727
               C3B0682729, C3B0682730, C3B0682731, C3B0682732, C3B0682733
               C3B06X2804, C3B06X2805, C3B06X2806, C3B06X2807, C3B06X2808
               C3B06X2809, C3B06X2810, C3B06X2811, C3B06X2812, C3B06X2813
               C3B06X2814, C3B06X2815, C3B06Y2926, C3B06Y2927, C3B06Y2929
               C3B06Y2931, C3B06Y2932, C3C06Y3028, C3C06Y3029, C3C06Y3030
               C3C06Y3031, C3C06Y3032, C3C06Z3112, C3C06Z3113, C3C06Z3114
               C3C06Z3115, C3C06Z3116, C3C06Z3141, C3C06Z3142, C3C06Z3144
               C3C06Z3145, C3C06Z3146, C3C06Z3147, C3C06Z3148, C3C06Z3149
               C3C06Z3150, C3C06Z3151, C3C06Z3152, C3C0713279, C3C0713280
               C3C0713281, C3C0713282, C3C0713283, C3C0713284, C3C0713352
               C3C0713353, C3C0713354, C3C0713355, C3C0713356, C3C0713357
               C3C0713358, C3C0713359, C3C0713360, C3C0713361, C3C0713362
               C3C0713363, C3C0713364, C3C0713365, C3C0713366, C3C0713367
               C3C0713368, C3C0713369, C3C0723466, C3C0723467, C3C0723468
               C3C0723469, C3C0723529, C3C0723530, C3C0723531, C3C0723532
               C3C0723533, C3C0723534, C3C0723535, C3C0723536, C3C0723554
               C3C0723555, C3C0723556, C3C0723557, C3C0723558, C3C0723559
               C3C0723560, C3C0723561, C3C0723562, C3C0723563, C3C0723564
               C3C0733600, C3C0733602, C3C0733603, C3C0733604, C3C0733605
               C3C0733606, C3C0733607, C3C0733608, C3C0733609, C3C0733734
               C3C0733735, C3C0733736, C3C0733738, C3C0733739, C3C0733740
               C3C0733741, C3C0743770, C3C0743771, C3C0743772, C3C0743819
               C3C0743820, C3C0743822, C3C0743825, C3C0743826, C3C0743828
               C3C0753925, C3C0753926, C3C0753927, C3C0753928, C3C0753929
               C3C0764005, C3D0774383, C4A0713218, C4A0713219, C4A0713220
               C4A0713221, C4A0713222, C4A0713311, C4A0713312, C4A0713313
               C4A0713314, C4A0713315, C4A0713316, C4A0713317, C4A0713318
               C4A0713319, C4A0713320, C4A0713321, C4A0713322, C4A0713323
               C4A0733649, C4A0733650, C4A0733651, C4A0733652, C4A0733653
               C4A0733654, C4A0733655, C4A0733656, C4A0733657, C4A0733658
               C4A0733659, C4A0733661, C4A0733662, C4A0743793, C4A0743794
               C4A0743795, C4A0743796, C4A0743797, C4A0743798, C4A0743799
               C4A0753909, C4A0753910, C4A0753912, C4A0753913, C4A0753917
               C4A0763990, C4A0763992
    
      出荷数量  :447台
        出荷時期  :平成 18 年 4 月〜平成 19 年 5 月
    
    
  3. 製造販売業者等名称

      製造販売業者の名称        :松下電器産業株式会社
      主たる機能を有する事業者の所在地:神奈川県横浜市都筑区佐江戸町600 番地
      薬事の業態            :第一種医療機器 製造販売業
      製造販売業許可番号        :14B1X00017
      製造所の名称        :パナソニック四国エレクトロニクス株式会社
      製造所の所在地        :神奈川県横浜市都筑区佐江戸町 600 番地
      薬事の業態          :医療機器 製造業
      製造業許可番号        :14BZ200060
    
    
  4. 改修理由

      開発、設計部門において、ソフトウエアの不具合により、以下のような問題が発生する場合
     があることが判明しましたので、当該装置について自主回収(改修)を実施致します。
    (1)Dynamic Flowモードからフル画面表示のパルスドップラモードに遷移した場合に、プロー
       ブ表面温度の上昇値がJIS T0601-2-37で定められた規格値を超えることがあります。
    (2)2Dモード多段フォーカス時に、モニタ上の表示値(MI/TI値)が取扱説明書に記載の最大値
       を超えて表示される場合があります。また、NEMIO SSA-550Aにおいて、特定のプローブ
       (PSM-70AT、PSM-50AT、PSM-37AT、 PVM-621VT)を使用した場合、表面温度の上昇値が
       JIS T0601-2-37で定められた規格値を超えることがあります。
    (3)モニタ上のTI値が正しく表示されないことがあります。
    
    
  5. 危惧される具体的な健康被害

      本問題により、プローブの温度が上昇する可能性はありますが、これによる重篤な健康被害が
      発生する可能性はないと考えています。
      なお、今までに本件による健康被害の報告は受けておりません。
    
    
  6. 改修開始年月日

      平成 19 年 9 月 7 日(情報提供の開始)
    
    
  7. 効能・効果又は用途等

      本装置は、超音波を用いて体内の形状、性状又は動態を可視化し、画像情報を診断のために
      提供するものです。
    
    
  8. その他

      納入しました医療機関はすべて特定しており、対象機器に対して改善済のソフトウエアを
      インストールする改修を実施致します。
    
    
  9. 担当者名及び連絡先

      連絡先  :松下電器産業株式会社 薬事統括グループ
      住所   :神奈川県横浜市都筑区佐江戸町 600 番地
      電話   :070-6406-0097または070-6406-0096
      FAX    :045-939-1765
      土日・祝日:070-6406-0097または070-6406-0096
      担当者  :飯島 啓司、大須賀 葉子