令和 4 年 9 月 2 日作成
医療機器改修の概要（クラス II）

1. 一般的名称及び販売名
一般的名称： 汎用人工呼吸器
販売名： サーボベンチレータ SERVO-air

2. 対象ロット、数量及び出荷時期
製造番号：
10170, 10178, 10184, 10188, 10190, 10191, 10192, 10193, 10194, 10195, 10196, 10197, 10198, 10199,
10200, 10201, 10202, 10203, 10204, 10205, 10206, 10208, 10209, 10210, 10211, 10212, 10213, 10214,
10215, 10216, 10217, 10219, 10220, 10221, 10222, 10223, 10224, 10227, 10228, 10229, 10232, 10233,
10234, 10235, 10236, 10237, 10238, 10239, 10241, 10244, 10248, 10249, 10254, 10255, 10256, 10258,
10259, 10260, 10261, 10263, 10264, 10265, 10266, 10267, 10268, 10269, 10270, 10276, 10277, 10279,
10284, 10285, 10287, 10288, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10303,
10304, 10307, 10308, 10310, 10312, 10313, 10314, 10315, 10317, 10319, 10320, 10321, 10322, 10324,
10325, 10326, 10327, 10329, 10330, 10332, 10333, 10338, 10339, 10340, 10342, 10344, 10345, 10346,
10352, 10353, 10357, 10362, 10367, 10368, 10372, 10379, 10383, 10384, 10387, 10388, 10390, 10392,
10395, 10399, 10400, 10401, 10402, 10403, 10404, 10405, 10406, 10414, 10415, 10416, 10417, 10419,
10420, 10421, 10422, 10423, 10424, 10425, 10433, 10438, 10439, 10440, 10443, 10447, 10452, 10456,
10458, 10460, 10462, 10465, 10468, 10469, 10471, 10474, 10477, 10478, 10479, 10480, 10481, 10483,
10484, 10486, 10487, 10488, 10489, 10490, 10491, 10501, 10502, 10503, 10508, 10509, 10514, 10520,
10522, 10523, 10536, 10539, 10546, 10547, 10599, 10600, 10601, 10602, 10614, 10615, 10618, 10619,
10646, 10647, 10648, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10661, 10664, 10667, 10670,
10685, 10696, 10697, 10708, 10728, 10744, 10745, 10749, 10761, 10788, 10790, 10791, 10792, 10793,
10794, 10795, 10797, 10798, 10799, 10800, 10801, 10802, 10803, 10804, 10813, 10826, 10827, 10829,
10832, 10833, 10834, 10835, 10838, 10839, 10840, 10841, 10842, 10845, 10846, 10847, 10850, 10856,
10863, 10864, 10865, 10867, 10874, 10875, 10876, 10877, 10878, 10879, 10884, 10893, 10894, 10895,
10902, 10909, 10914, 10915, 10916, 10917, 10921, 10922, 10923, 10924, 10925, 10926, 10927, 10928,
10929, 10930, 10932, 10933, 10935, 10936, 10938, 10950, 10957, 10959, 10960, 10961, 10963, 10964,
10965, 10968, 10969, 10970, 10971, 10972, 10973, 10975, 10976, 10990, 10996, 10997, 10999, 11000,
11002, 11003, 11004, 11005, 11006, 11007, 11009, 11010, 11011, 11012, 11014, 11016, 11017, 11019,
11020, 11021, 11023, 11024, 11026, 11027, 11028, 11030, 11031, 11035, 11036, 11037, 11041, 11042,
11044, 11046, 11047, 11048, 11049, 11050, 11052, 11054, 11055, 11056, 11057, 11058, 11059, 11061,
11066, 11067, 11070, 11072, 11073, 11074, 11075, 11076, 11078, 11079, 11080, 11081, 11082, 11083,
11084, 11085, 11086, 11087, 11089, 11090, 11091, 11092, 11093, 11094, 11095, 11096, 11097, 11098,
11099, 11100, 11101, 11102, 11103, 11104, 11105, 11106, 11107, 11109, 11110, 11114, 11115, 11116,
11117, 11118, 11119, 11120, 11121, 11122, 11123, 11124, 11125, 11126, 11127, 11128, 11129, 11131,
11132, 11133, 11134, 11135, 11136, 11137, 11139, 11140, 11141, 11142, 11143, 11144, 11145, 11146,
11147, 11148, 11152, 11153, 11154, 11155, 11156, 11157, 11158, 11159, 11160, 11161, 11162, 11163,
11164, 11165, 11166, 11167, 11168, 11169, 11170, 11171, 11172, 11178, 11179, 11181, 11185, 11186,
11188, 11190, 11193, 11194, 11196, 11197, 11199, 11201, 11210, 11217, 11220, 11221, 11222, 11223,
11225, 11226, 11227, 11229, 11234, 11238, 11240, 11242, 11244, 11245, 11339, 11372, 11377, 11378,
11379, 11380, 11381, 11382, 11383, 11385, 11386, 11387, 11388, 11390, 11391, 11392, 11394, 11396,
11397, 11400, 11401, 11403, 11404, 11407, 11408, 11409, 11410, 11411, 11412, 11413, 11414, 11415,
11416, 11417, 11418, 11419, 11420, 11421, 11422, 11423, 11426, 11427, 11428, 11429, 11430, 11433,
11434, 11438, 11441, 11442, 11449, 11450, 11451, 11452, 11453, 11454, 11455, 11456, 11457, 11458,
11459, 11463, 11464, 11465, 11466, 11468, 11469, 11470, 11471, 11472, 11473, 11474, 11477, 11480,
11481, 11484, 11485, 11486, 11487, 11488, 11490, 11491, 11492, 11493, 11495, 11496, 11497, 11498,
11499, 11500, 11501, 11502, 11503, 11504, 11505, 11518, 11519, 11520, 11521, 11522, 11523, 11524,
11525, 11526, 11527, 11528, 11530, 11532, 11533, 11534, 11535, 11537, 11538, 11539, 11540, 11612,
11614, 11637, 11639, 11642, 11643, 11644, 11645, 11646, 11647, 11648, 11649, 11650, 11651, 11652,
11653, 11654, 11655, 11656, 11657, 11733, 11734, 11735, 11736, 11737, 11738, 11739, 11740, 11741,
11742, 11743, 11744, 11745, 11746, 11747, 11748, 11749, 11750, 11751, 11752, 11753, 11754, 11755,
11756, 11757, 11758, 11759, 11760, 11761, 11762, 11763, 11764, 11765, 11766, 11768, 11769, 11770,
11771, 11772, 11773, 11774, 11775, 11776, 11777, 11778, 11779, 11780, 11781, 11782, 11783, 11784,
11785, 11786, 11787, 11788, 11789, 11790, 11791, 11792, 11793, 11801, 11802, 11803, 11804, 11805,
11806, 11807, 11808, 11809, 11810, 11811, 11812, 11813, 11814, 11815, 11816, 11817, 11818, 11819,
11820, 12006, 12029, 12058, 12059, 12060, 12061, 12062, 12063, 12064, 12065, 12066, 12067, 12068,
12069, 12070, 12071, 12072, 12073, 12074, 12075, 12076, 12095, 12096, 12097, 12098, 12099, 12100,
12101, 12102, 12103, 12105, 12106, 12107, 12108, 12109, 12111, 12113, 12114, 12115, 12116, 12224,
12226, 12230, 12231, 12232, 12233, 12234, 12235, 12236, 12237, 12238, 12239, 12242, 12243, 12244,

12245, 12246, 12247, 12248, 12249, 12250, 12251, 12252, 12253, 12254, 12255, 12256, 12257, 12258,
12259, 12288, 12289, 12290, 12291, 12292, 12293, 12294, 12295, 12296, 12297, 12298, 12299, 12300,
12301, 12302, 12303, 12304, 12305, 12306, 12307, 12308, 12309, 12311, 12312, 12313, 12314, 12316,
12317, 12318, 12319, 12320, 12321, 12322, 12323, 12324, 12325, 12326, 12327, 12328, 12330, 12356,
12357, 12358, 12359, 12360, 12361, 12362, 12363, 12364, 12365, 12524, 12541, 12545, 12560, 12561,
12562, 12565, 12566, 12567, 12568, 12569, 12570, 12571, 12579, 12580, 12584, 12585, 12586, 12588,
12589, 12593, 12654, 12656, 12657, 12658, 12660, 12661, 12662, 12663, 12664, 12665, 12666, 12667,
12668, 12669, 12670, 12671, 12672, 12673, 12674, 12675, 12676, 12677, 12678, 12679, 12680, 12681,
12682, 12683, 12684, 12686, 12687, 12690, 12691, 12692, 12693, 12694, 12695, 12696, 12697, 12698,
12699, 12710, 12711, 12712, 12713, 12714, 12715, 12716, 12717, 12718, 12719, 12947, 12948, 12952,
12953, 12954, 12955, 12956, 12957, 12958, 12959, 12960, 13006, 13008, 13009, 13012, 13013, 13016,
13017, 13018, 13020, 13022, 13023, 13026, 13029, 13033, 13055, 13056, 13057, 13058, 13059, 13060,
13061, 13062, 13063, 13064, 13065, 13066, 13067, 13068, 13069, 13070, 13071, 13072, 13073, 13074,
13116, 13123, 13125, 13126, 13128, 13130, 13132, 13135, 13136, 13137, 13145, 13146, 13149, 13150,
13152, 13153, 13154, 13155, 13156, 13157, 13204, 13205, 13211, 13221, 13228, 13229, 13237, 13238,
13244, 13271, 13327, 13365, 13366, 13367, 13368, 13375, 13376, 13378, 13379, 13380, 13381, 13382,
13383, 13384, 13385, 13386, 13388, 13390, 13392, 13393, 13394, 13395, 13396, 13397, 13398, 13399,
13400, 13401, 13402, 13403, 13405, 13406, 13408, 13410, 13411, 13412, 13413, 13414, 13416, 13417,
13419, 13421, 13422, 13423, 13425, 13427, 13428, 13429, 13430, 13431, 13432, 13433, 13434, 13435,
13436, 13438, 13439, 13442, 13443, 13444, 13454, 13463, 13464, 13465, 13467, 13468, 13469, 13470,
13471, 13472, 13473, 13474, 13476, 13477, 13478, 13479, 13481, 13482, 13484, 13485, 13537, 13572,
13575, 13598, 13599, 13600, 13601, 13602, 13603, 13607, 13608, 13609, 13611, 13612, 13613, 13614,
13615, 13616, 13617, 13618, 13620, 13621, 13622, 13623, 13624, 13627, 13628, 13629, 13630, 13631,
13632, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13641, 13642, 13643, 13644, 13645,
13646, 13647, 13648, 13760, 13761, 13762, 13764, 13765, 13766, 13767, 13768, 13769, 13770, 13771,
13772, 13773, 13774, 13775, 13776, 13777, 13778, 13779, 13780, 13831, 13832, 13833, 13834, 13835,
13836, 13837, 13850, 13867, 13868, 13869, 13870, 13871, 13872, 13873, 13874, 13875, 13876, 13877,
13878, 13879, 13880, 13882, 13886, 13887, 13888, 13889, 13890, 13892, 13893, 13894, 13895, 13896,
13898, 13899, 13900, 13901, 13902, 13903, 13904, 13905, 13906, 13919, 13921, 13922, 13924, 13926,
13928, 13930, 13932, 13933, 13934, 13935, 13940, 13941, 13942, 13943, 13945, 13946, 13947, 13948,
13949, 13963, 13965, 14005, 14006, 14007, 14008, 14009, 14010, 14011, 14012, 14013, 14014, 14025,
14026, 14027, 14028, 14029, 14030, 14031, 14032, 14033, 14034, 14041, 14042, 14043, 14044, 14045,
14067, 14068, 14069, 14070, 14071, 14072, 14073, 14074, 14075, 14076, 14077, 14078, 14079, 14080,
14081, 14082, 14083, 14084, 14085, 14086, 14136, 14137, 14138, 14140, 14141, 14142, 14143, 14144,
14145, 14146, 14147, 14148, 14149, 14151, 14152, 14153, 14154, 14155, 14156, 14157, 14337, 14338,
14339, 14340, 14341, 14342, 14343, 14344, 14345, 14346, 14347, 14348, 14349, 14350, 14351, 14352,
14353, 14354, 14355, 14356, 14438, 14439, 14440, 14441, 14442, 14443, 14444, 14445, 14446, 14447,
14448, 14449, 14450, 14452, 14453, 14454, 14455, 14456, 14457, 14458, 14468, 14469, 14470, 14471,
14472, 14473, 14474, 14475, 14476, 14477, 14478, 14479, 14480, 14481, 14482, 14483, 14484, 14485,
14486, 14487, 14494, 14495, 14496, 14497, 14498, 14499, 14500, 14501, 14502, 14503, 14504, 14505,
14506, 14508, 14509, 14510, 14511, 14512, 14513, 14514, 14575, 14576, 14577, 14578, 14579, 14580,
14581, 14582, 14583, 14584, 14585, 14586, 14587, 14588, 14589, 14590, 14591, 14592, 14593, 14594,
14595, 14596, 14598, 14599, 14600, 14601, 14602, 14620, 14621, 14622, 14623, 14624, 14626, 14627,
14628, 14629, 14630, 14631, 14632, 14633, 14691, 14692, 14693, 14694, 14695, 14696, 14697, 14698,
14699, 14700, 14701, 14702, 14703, 14704, 14705, 14706, 14707, 14708, 14709, 14710, 14724, 14725,
14726, 14727, 14728, 14729, 14730, 14731, 14732, 14733, 14734, 14735, 14736, 14737, 14738, 14739,
14740, 14741, 14742, 14743, 14801, 14802, 14803, 14804, 14805, 14806, 14807, 14808, 14809, 14810,
14811, 14812, 14813, 14814, 14815, 14816, 14817, 14818, 14819, 14820, 14836, 14837, 14838, 14839,
14840, 14841, 14842, 14843, 14844, 14845, 14846, 14847, 14848, 14849, 14850, 14851, 14852, 14853,
14854, 14855, 14856, 14857, 14858, 14859, 14860, 14861, 14862, 14863, 14864, 14865, 14866, 14867,
14868, 14869, 14870, 14871, 14872, 14873, 14874, 14875, 15035, 15036, 15037, 15038, 15039, 15040,
15041, 15042, 15043, 15044, 15045, 15046, 15047, 15048, 15049, 15050, 15051, 15052, 15053, 15054,
15094, 15095, 15096, 15097, 15098, 15099, 15100, 15101, 15103, 15104, 15105, 15106, 15107, 15108,
15109, 15110, 15112, 15113, 15114, 15115, 15117, 15118, 15119, 15120, 15121, 15122, 15123, 15124,
15125, 15126, 15127, 15128, 15129, 15130, 15131, 15132, 15133, 15134, 15135, 15136, 15157, 15158,
15159, 15160, 15161, 15162, 15163, 15164, 15165, 15166, 15167, 15168, 15169, 15170, 15171, 15172,
15173, 15174, 15175, 15176, 15177, 15178, 15179, 15180, 15181, 15184, 15185, 15186, 15187, 15188,
15189, 15190, 15191, 15192, 15193, 15194, 15195, 15196, 15197, 15198, 15478, 15479, 15480, 15481,
15482, 15483, 15484, 15485, 15486, 15487, 15488, 15489, 15490, 15491, 15495, 15496, 15498, 15499,
15500, 15513, 16180, 16181, 16182, 16183, 16184, 16185, 16186, 16187, 16188, 16189, 16345, 16346,
16347, 16348, 16349, 16350, 16351, 16352, 16353, 16354, 16421, 16422, 16423, 16426, 16427, 16428,
16429, 16430, 16511, 16512, 16572, 16573, 16574, 16575, 16578, 16579, 16580, 16581, 16582, 16603,
16676, 16682, 16683, 16684, 16685, 16686, 16687, 16688, 16689, 16690, 16691, 16692, 16693, 16695,
16696, 16728, 16922, 16923, 16924, 16925, 16926, 16927, 16928, 16929, 16930, 16931, 16932, 16933,
16934, 16935, 16936, 16937, 16938, 16939, 16940, 16941, 16952, 16953, 16954, 16955, 16956, 16957,
16958, 16959, 16960, 16961, 16962, 16963, 16964, 16965, 16966, 16967, 16968, 16969, 16970, 16971,

17012, 17013, 17014, 17015, 17016, 17017, 17018, 17019, 17020, 17021, 17022, 17023, 17024, 17025,
17026, 17027, 17028, 17029, 17030, 17031, 17042, 17043, 17044, 17045, 17046, 17047, 17048, 17049,
17050, 17051, 17052, 17053, 17054, 17055, 17056, 17057, 17058, 17059, 17060, 17061, 17238, 17239,
17240, 17241, 17242, 17243, 17244, 17245, 17246, 17247, 17248, 17249, 17250, 17251, 17252, 17253,
17254, 17255, 17256, 17257, 17258, 17259, 17260, 17261, 17262, 17263, 17264, 17265, 17266, 17267,
17268, 17269, 17270, 17271, 17272, 17273, 17274, 17275, 17276, 17277, 17427, 17428, 17429, 17430,
17431, 17432, 17433, 17434, 17435, 17436, 17437, 17438, 17439, 17440, 17441, 17442, 17443, 17444,
17445, 17446, 17574, 17575, 17576, 17577, 17578, 17579, 17580, 17581, 17582, 17583, 17584, 17585,
17586, 17587, 17588, 17589, 17590, 17591, 17592, 17594, 17595, 17599, 17600, 17601, 17602, 17603,
17604, 17606, 17607, 17608, 17609, 17610, 17611, 17612, 17613, 17614, 17615, 17616, 17617, 17618,
17619, 17620, 17621, 17622, 17623, 17624, 17625, 17626, 17687, 17688, 17689, 17690, 17691, 17692,
17693, 17694, 17695, 17696, 17697, 17698, 17699, 17700, 17701, 17702, 17703, 17704, 17705, 17706,
17707, 17708, 17709, 17710, 17711, 17712, 17713, 17714, 17715, 17716, 17717, 17718, 17719, 17720,
17721, 17722, 17724, 17725, 17726, 17727, 17728, 17729, 17730, 17731, 17732, 17794, 17825, 17857,
17858, 17859, 17860, 17861, 17862, 17863, 17864, 17865, 17866, 17867, 17868, 17869, 17870, 17871,
17872, 17873, 17874, 17875, 17876, 17877, 17878, 17879, 17880, 17881, 17882, 17883, 17884, 17885,
17886, 17887, 17888, 17889, 17890, 17891, 17892, 18068, 18069, 18070, 18071, 18072, 18073, 18074,
18075, 18076, 18077, 18078, 18079, 18080, 18081, 18082, 18083, 18086, 18087, 18088, 18091, 18093,
18094, 18096, 18098, 18099, 18113, 18114, 18115, 18117, 18119, 18120, 18121, 18122, 18123, 18124,
18499, 18500, 18501, 18502, 18503, 18504, 18505, 18506, 18507, 18508, 18562, 18563, 18564, 18565,
18566, 18567, 18568, 18569, 18570, 18571, 18572, 18573, 18574, 18575, 18576, 18577, 18578, 18579,
18580, 18581, 18582, 18600, 18601, 18602, 18603, 18604, 18605, 18606, 18607, 18608, 18609, 18610,
18611, 18612, 18613, 18614, 18770, 18771, 18772, 18773, 18774, 18775, 18776, 18777, 18778, 18779,
18780, 18781, 18782, 18783, 18785, 18788, 18822, 18824, 18826, 18827, 18828, 18839, 18840, 18841,
18845, 18846, 18847, 18849, 18850, 18851, 18852, 18853, 18857, 18858, 18860, 18861, 18881, 18882,
18883, 18884, 18885, 18886, 18887, 18888, 18889, 18890, 18891, 18892, 18893, 18894, 18895, 18896,
18897, 18898, 18899, 18900, 18961, 18963, 18964, 18965, 18972, 18973, 18974, 18975, 18976, 18978,
18979, 18980, 18981, 18982, 18984, 18990, 18995, 18996, 18997, 18999, 19002, 19003, 19005, 19006,
19007, 19009, 19013, 19014, 19016, 19017, 19020, 19022, 19024, 19025, 19028, 19029, 19030, 19032,
19036, 19039, 19040, 19041, 19042, 19043, 19045, 19046, 19048, 19049, 19051, 19053, 19054, 19055,
19057, 19059, 19060, 19062, 19064, 19067, 19068, 19069, 19071, 19073, 19075, 19079, 19081, 19092,
19108, 19110, 19111, 19112, 19114, 19115, 19116, 19118, 19120, 19121, 19123, 19124, 19125, 19126,
19127, 19128, 19129, 19130, 19132, 19134, 19141, 19143, 19148, 19155, 19156, 19157, 19158, 19159,
19164, 19165, 19167, 19169, 19170, 19171, 19173, 19175, 19178, 19179, 19181, 19183, 19185, 19186,
19192, 19193, 19195, 19196, 19198, 19202, 19203, 19204, 19205, 19206, 19207, 19208, 19209, 19211,
19212, 19214, 19215, 19216, 19218, 19219, 19220, 19221, 19223, 19225, 19227, 19228, 19229, 19230,
19231, 19451, 19527, 19528, 19530, 19532, 19533, 19535, 19536, 19538, 19540, 19543, 19546, 19547,
19549, 19551, 19553, 19555, 19557, 19559, 19562, 19563, 19565, 19568, 19569, 19571, 19573, 19575,
19577, 19578, 19581, 19583, 19586, 19588, 19589, 19592, 19594, 19596, 19598, 19599, 19601, 19602,
19604, 19606, 19608, 19610, 19611, 19614, 19615, 19617, 19653, 19682, 19685, 19687, 19689, 19691,
19692, 19694, 19696, 19698, 19700, 19703, 19705, 19707, 19709, 19710, 19711, 19712, 19713, 19716,
19718, 19721, 19725, 19727, 19729, 19730, 19733, 19735, 19738, 19740, 19741, 19743, 19745, 20621,
20622, 20623, 20624, 20625, 20626, 20627, 20628, 20632, 20633, 20634, 20635, 20636, 20637, 20638,
20639, 20640, 20641, 20642, 20643, 20644, 20645, 20651, 20652, 20653, 20654, 20655, 20656, 20657,
20658, 20659, 20660, 20661, 20662, 20663, 20664, 20666, 20667, 20668, 20669, 20670, 20675, 20676,
20677, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20688, 20689, 20690,
20691, 20692, 20693, 20694, 20695, 20696, 20697, 20698, 20699, 20700, 20701, 20702, 20703, 20704,
20708, 20709, 20710, 20711, 20712, 20713, 20714, 20715, 20716, 20717, 20718, 20719, 20720, 20721,
20722, 20723, 20724, 20725, 20726, 20727, 20728, 20729, 20730, 20731, 20732, 20733, 20734, 20735,
20736, 20737, 20738, 20739, 20740, 20741, 20742, 20743, 20744, 20745, 20746, 20747, 20748, 20749,
20750, 20751, 20776, 20777, 20778, 20779, 20780, 20781, 20782, 20783, 20784, 20785, 20865, 20866,
20867, 20868, 20869, 20870, 20871, 20872, 20873, 20874, 20907, 20908, 20909, 20910, 20911, 20912,
20913, 20914, 20915, 20916, 20917, 20918, 20919, 20920, 20922, 20923, 20924, 20931, 20932, 20933,
20934, 20935, 20936, 20937, 20938, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20946, 20947,
20948, 20949, 20950, 20951, 20952, 20953, 20954, 20955, 20956, 20957, 20958, 20959, 20960, 20961,
20962, 20963, 20964, 20965, 20966, 20967, 20968, 20969, 20970, 20971, 20972, 20973, 20974, 20975,
20976, 20977, 20978, 20979, 20980, 20981, 20982, 20983, 20984, 20985, 20986, 20987, 20988, 20989,
20990, 21016, 21055, 21056, 21057, 21058, 21059, 21060, 21061, 21062, 21063, 21064, 21065, 21066,
21067, 21068, 21069, 21070, 21071, 21072, 21073, 21074, 21075, 21076, 21077, 21078, 21079, 21080,
21081, 21082, 21083, 21084, 21085, 21086, 21087, 21088, 21089, 21090, 21091, 21092, 21093, 21094,
21113, 21123, 21125, 21145, 21146, 21147, 21148, 21149, 21150, 21151, 21152, 21153, 21154, 21155,
21156, 21157, 21158, 21159, 21160, 21161, 21162, 21163, 21164, 21165, 21166, 21167, 21168, 21169,
21170, 21171, 21172, 21173, 21174, 21175, 21176, 21177, 21178, 21179, 21180, 21181, 21182, 21183,
21184, 21185, 21186, 21187, 21188, 21189, 21190, 21191, 21192, 21193, 21194, 21196, 21197, 21198,
21199, 21200, 21201, 21202, 21203, 21204, 22272, 22273, 22274, 22275, 22276, 22277, 22278, 22279,
22280, 22281, 22282, 22284, 22285, 22286, 22287, 22288, 22289, 22290, 22291, 22292, 22332, 22333,

22334, 22335, 22336, 22337, 22338, 22339, 22340, 22341, 22342, 22343, 22344, 22348, 22349, 22351,
22352, 22353, 22354, 22355, 22356, 22357, 22358, 22359, 22360, 22361, 22362, 22363, 22364, 22365,
22415, 22416, 22417, 22418, 22419, 22420, 22421, 22422, 22423, 22424, 22425, 22426, 22427, 22428,
22429, 22430, 22431, 22432, 22433, 22434, 22445, 22446, 22447, 22448, 22449, 22450, 22451, 22452,
22453, 22454, 22455, 22456, 22457, 22458, 22459, 22460, 22461, 22462, 22463, 22464, 22482, 22483,
22484, 22485, 22486, 22487, 22488, 22489, 22490, 22492, 22525, 22526, 22528, 22529, 22530, 22531,
22532, 22533, 22534, 22535, 22626, 22627, 22628, 22629, 22630, 22631, 22632, 22633, 22634, 22635,
22661, 22662, 22663, 22664, 22665, 22666, 22667, 22668, 22669, 22670, 22671, 22672, 22673, 22674,
22675, 22676, 22677, 22678, 22679, 22680, 22762, 22763, 22764, 22765, 22766, 22767, 22768, 22769,
22770, 22771, 22814, 22815, 22816, 22817, 22818, 22819, 22820, 22821, 22822, 22823, 22824, 22825,
22826, 22827, 22828, 22829, 22830, 22831, 22833, 22834, 22835, 22836, 22837, 22838, 22839, 22840,
22841, 22842, 22843, 22844, 22845, 22846, 22847, 22848, 22849, 22850, 22851, 22852, 22853, 22854,
22855, 22856, 22857, 22858, 22859, 22860, 22861, 22862, 22863, 22864, 22990, 22991, 22992, 22993,
22994, 22996, 22997, 22998, 22999, 23001, 23002, 23004, 23005, 23007, 23008, 23009, 23010, 23011,
23012, 23013, 23014, 23015, 23016, 23017, 23018, 23019, 23020, 23021, 23022, 23023, 23024, 23025,
23026, 23027, 23028, 23029, 23030, 23031, 23032, 23033, 23040, 23041, 23042, 23043, 23044, 23045,
23046, 23047, 23048, 23049, 23195, 23196, 23197, 23198, 23199, 23200, 23201, 23202, 23203, 23204,
23205, 23206, 23207, 23208, 23209, 23210, 23211, 23212, 23213, 23214, 23215, 23216, 23217, 23218,
23219, 23220, 23221, 23222, 23223, 23224, 23225, 23226, 23227, 23228, 23229, 23230, 23231, 23232,
23233, 23234, 23235, 23236, 23237, 23238, 23239, 23240, 23241, 23242, 23243, 23244, 23245, 23246,
23247, 23248, 23249, 23250, 23251, 23252, 23253, 23254, 23259, 23260, 23261, 23262, 23263, 23264,
23265, 23266, 23267, 23268, 23297, 23298, 23299, 23300, 23301, 23302, 23303, 23304, 23305, 23306,
23307, 23308, 23309, 23310, 23311, 23312, 23313, 23314, 23315, 23316, 23317, 23318, 23319, 23320,
23321, 23322, 23323, 23324, 23325, 23326, 23540, 23541, 23542, 23543, 23544, 23545, 23546, 23547,
23548, 23550, 23553, 23554, 23555, 23556, 23557, 23558, 23559, 23560, 23561, 23562, 23564, 23565,
23566, 23567, 23568, 23569, 23570, 23571, 23572, 23573, 23574, 23575, 23576, 23577, 23578, 23579,
23580, 23581, 23582, 23583, 23584, 23585, 23586, 23587, 23588, 23589, 23590, 23591, 23592, 23593,
23627, 23628, 23629, 23630, 23631, 23632, 23633, 23634, 23635, 23636, 23639, 23640, 23641, 23642,
23643, 23644, 23645, 23646, 23647, 23648, 23701, 23702, 23703, 23704, 23705, 23706, 23707, 23708,
23709, 23710, 23711, 23712, 23713, 23714, 23715, 23716, 23717, 23718, 23719, 23720, 23735, 23740,
23741, 23742, 23743, 23744, 23745, 23746, 23747, 23748, 23764, 23765, 23766, 23767, 23768, 23769,
23770, 23771, 23772, 23773, 23774, 23775, 23776, 23777, 23778, 23779, 23780, 23781, 23782, 23783,
23793, 23794, 23795, 23796, 23797, 23798, 23799, 23800, 23801, 23802, 23803, 23804, 23805, 23806,
23807, 23808, 23809, 23810, 23811, 23812, 23813, 23814, 23815, 23816, 23817, 23818, 23819, 23820,
23821, 23822, 23828, 23829, 23830, 23831, 23832, 23833, 23834, 23835, 23836, 23837, 23838, 23839,
23840, 23841, 23842, 23843, 23844, 23845, 23846, 23847, 24057, 24058, 24059, 24060, 24061, 24062,
24063, 24064, 24065, 24071, 24072, 24073, 24074, 24075, 24076, 24077, 24079, 24080
出荷数量：3106 台
出荷時期：平成 28 年 4 月 22 日～

令和 4 年 8 月 1 日

3. 製造販売業者等名称
製造販売業者の名称 ： フクダ電子株式会社
製造販売業者の所在地： 東京都文京区本郷三丁目３９番４号
許可の種類： 第一種医療機器製造販売業
許可番号： 13B1X00003

4. 改修理由（１）
輸入先製造業者よりごく稀に呼吸システムのソフトウェアの誤動作によりテクニカルアラーム（アラーム音とメッセージの表示）が発生し換気を停止する可能性があるとの報告を受けました。自主改修として改良したソフト
ウェアへのアップデートを実施します。
（２）
最新の垂直荷重規格（IEC 60601-1 §9.4.2.3 b）にユーザーがホイールベースを踏むことにより機器が転倒しないよう記載されています。最新規格適合のためホイールベースを踏まないようにホイールベース部（4 か所）に注意ラベルを貼付します。

5. 危惧される具体的な健康被害
ソフトウェアの誤動作が発生した場合、安全弁と呼気弁を開放しアラームが発生するため直ぐに気付くことが出来ます。また、ホイールベースを踏み機器が転倒した場合もその場で気付くことが出来ます。本機は医療従事者の監視下で使用されることから適切に対処する事が出来、重篤な健康被害に至る可能性はないと考えております。
尚、国内において健康被害の報告は受けておりません。

6. 改修開始年月日
令和 4 年 8 月 31 日

7. 効能・効果又は用途等
本装置は、酸素と空気の混合ガスを機械的調節のもとで、口腔または鼻孔を通じて肺に導入し人工的に呼吸を行わせる人工呼吸器です。

8. その他
本件に係わる装置の納入先は全て把握しており、納入先に情報を提供するとともに改修を実施致します。

9. 担当者及び連絡先
担当者 ： 田北 徳生、石井 義弘
連絡先 ： フクダ電子株式会社
東京都文京区本郷二丁目３５番８号
電話番号： ０３（５６８４）１６９４
FAX 番号 ： ０３（５６８４）１３９８