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平成１６年６月３日作成
医療用具回収の概要
（クラスII）
一般名 ： 自動腹膜灌流装置 販売名 ： ホームＡＰＤシステムゆめ
出荷時期 ： 平成１４年８月より平成１６年５月 数量 ： ３１１９台 (バージョン８．５及び８．６ ソフトウェア搭載機) 対象シリアル： 添付記載 添付 ： 対象シリアル 40007, 40035, 40040, 40049, 40053, 40059, 40068, 40076, 40078, 40081, 40082, 40096, 40097, 40098, 40106, 40108, 40111, 40112, 40114, 40119, 40122, 40125, 40129, 40134, 40144, 40146, 40156, 40157, 40159, 40160, 40162, 40164, 40169, 40170, 40177, 40182, 40183, 40184, 40189, 40190, 40192, 40216, 40217, 40218, 40219, 40221, 40223, 40224, 40226, 40227, 40228, 40229, 40230, 40231, 40233, 40234, 40238, 40241, 40242, 40243, 40246, 40247, 40248, 40249, 40250, 40251, 40252, 40255, 40256, 40258, 40259, 40266, 40267, 40268, 40271, 40274, 40275, 40276, 40278, 40279, 40282, 40284, 40286, 40287, 40289, 40291, 40293, 40297, 40299, 40301, 40302, 40304, 40305, 40307, 40309, 40311, 40312, 40314, 40315, 40316, 40320, 40321, 40322, 40323, 40325, 40326, 40328, 40329, 40330, 40331, 40332, 40333, 40334, 40335, 40336, 40338, 40339, 40341, 40342, 40343, 40344, 40345, 40346, 40347, 40350, 40351, 40353, 40355, 40357, 40358, 40359, 40361, 40364, 40365, 40366, 40367, 40368, 40369, 40373, 40377, 40378, 40380, 40382, 40383, 40386, 40387, 40388, 40389, 40393, 40394, 40395, 40396, 40397, 40399, 40401, 40402, 40403, 40408, 40409, 40410, 40412, 40413, 40414, 40416, 40417, 40420, 40422, 40423, 40424, 40425, 40427, 40428, 40431, 40434, 40437, 40438, 40444, 40445, 40448, 40451, 40453, 40456, 40460, 40461, 40462, 40463, 40469, 40470, 40472, 40473, 40474, 40475, 40476, 40478, 40479, 40481, 40483, 40484, 40486, 40487, 40489, 40490, 40491, 40492, 40493, 40495, 40496, 40497, 40504, 40505, 40507, 40511, 40512, 40514, 40515, 40516, 40517, 40520, 40522, 40524, 40525, 40529, 40530, 40531, 40534, 40535, 40536, 40537, 40538, 40540, 40541, 40542, 40545, 40549, 40550, 40554, 40555, 40556, 40557, 40559, 40561, 40565, 40566, 40568, 40571, 40572, 40573, 40574, 40577, 40578, 40579, 40584, 40586, 40587, 40595, 40597, 40600, 40602, 40603, 40604, 40605, 40606, 40608, 40609, 40612, 40613, 40614, 40615, 40616, 40618, 40622, 40624, 40625, 40626, 40627, 40628, 40632, 40635, 40636, 40637, 40639, 40644, 40646, 40647, 40648, 40649, 40650, 40651, 40653, 40655, 40659, 40660, 40661, 40662, 40663, 40664, 40665, 40666, 40667, 40668, 40670, 40671, 40673, 40674, 40675, 40676, 40677, 40678, 40685, 40687, 40688, 40690, 40691, 40692, 40693, 40695, 40698, 40699, 40700, 40702, 40703, 40704, 40705, 40706, 40707, 40709, 40712, 40716, 40717, 40718, 40719, 40720, 40724, 40725, 40726, 40728, 40729, 40731, 40732, 40733, 40734, 40735, 40737, 40739, 40740, 40741, 40742, 40743, 40747, 40749, 40752, 40753, 40754, 40755, 40757, 40759, 40760, 40762, 40763, 40764, 40765, 40768, 40771, 40773, 40775, 40777, 40779, 40780, 40781, 40782, 40786, 40788, 40789, 40790, 40793, 40795, 40799, 40802, 40803, 40806, 40809, 40811, 40812, 40814, 40815, 40817, 40818, 40819, 40822, 40823, 40824, 40826, 40827, 40829, 40830, 40831, 40834, 40835, 40836, 40837, 40838, 40839, 40841, 40842, 40846, 40847, 40848, 40850, 40851, 40853, 40855, 40857, 40859, 40860, 40861, 40863, 40864, 40865, 40866, 40867, 40868, 40870, 40871, 40872, 40875, 40876, 40877, 40879, 40880, 40883, 40884, 40885, 40887, 40889, 40894, 40895, 40896, 40897, 40898, 40900, 40901, 40902, 40903, 40905, 40906, 40907, 40909, 40910, 40911, 40915, 40916, 40924, 40926, 40928, 40929, 40930, 40932, 40933, 40935, 40938, 40945, 40946, 40949, 40950, 42001, 42004, 42005, 42006, 42007, 42009, 42011, 42015, 42019, 42020, 42023, 42024, 42025, 42028, 42029, 42036, 42037, 42039, 42040, 42041, 42042, 42043, 42047, 42049, 42051, 42053, 42056, 42057, 42059, 42061, 42062, 42065, 42067, 42069, 42072, 42073, 42074, 42076, 42079, 42081, 42083, 42088, 42089, 42091, 42093, 42094, 42097, 42099, 42100, 42103, 42105, 42109, 42110, 42111, 42114, 42116, 42117, 42118, 42121, 42122, 42123, 42125, 42126, 42128, 42129, 42130, 42131, 42132, 42133, 42139, 42140, 42145, 42146, 42149, 42150, 42151, 42152, 42156, 42158, 42160, 42161, 42162, 42164, 42165, 42166, 42168, 42170, 42171, 42172, 42175, 42176, 42177, 42178, 42180, 42181, 42184, 42185, 42186, 42187, 42188, 42190, 42192, 42193, 42194, 42197, 42198, 42202, 42203, 42204, 42205, 42206, 42207, 42208, 42212, 42213, 42214, 42215, 42216, 42218, 42220, 42222, 42226, 42231, 42233, 42234, 42235, 42237, 42238, 42240, 42242, 42243, 42244, 42246, 42249, 42252, 42253, 42255, 42256, 42257, 42258, 42261, 42262, 42263, 42265, 42266, 42269, 42272, 42274, 42275, 42277, 42278, 42279, 42280, 42281, 42285, 42287, 42290, 42291, 42293, 42294, 42296, 42297, 42298, 42301, 42302, 42303, 42304, 42305, 42306, 42307, 42309, 42310, 42312, 42313, 42316, 42319, 42320, 42321, 42324, 42325, 42326, 42327, 42328, 42329, 42331, 42332, 42333, 42335, 42336, 42337, 42338, 42341, 42342, 42344, 42345, 42348, 42349, 42350, 42352, 42353, 42354, 42357, 42360, 42361, 42364, 42366, 42367, 42368, 42369, 42371, 42374, 42376, 42377, 42378, 42382, 42383, 42384, 42385, 42387, 42388, 42389, 42390, 42391, 42392, 42393, 42397, 42398, 42399, 42401, 42402, 42406, 42408, 42409, 42410, 42411, 42413, 42415, 42416, 42417, 42418, 42420, 42421, 42423, 42424, 42425, 42427, 42428, 42429, 42431, 42433, 42434, 42435, 42438, 42440, 42443, 42445, 42446, 42447, 42448, 42450, 42453, 42455, 42456, 42458, 42459, 42460, 42462, 42463, 42465, 42467, 42469, 42470, 42474, 42475, 42477, 42478, 42479, 42480, 42481, 42482, 42484, 42485, 42486, 42488, 42489, 42491, 42495, 42497, 42498, 42500, 42501, 42502, 42503, 42504, 42509, 42511, 42512, 42513, 42514, 42517, 42519, 42520, 42522, 42524, 42525, 42527, 42529, 42530, 42531, 42533, 42535, 42537, 42543, 42544, 42547, 42548, 42549, 42551, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42559, 42560, 42561, 42562, 42563, 42564, 42565, 42570, 42571, 42572, 42573, 42575, 42576, 42579, 42582, 42583, 42584, 42586, 42587, 42588, 42589, 42590, 42591, 42592, 42593, 42594, 42595, 42596, 42598, 42600, 42604, 42605, 42608, 42611, 42612, 42616, 42617, 42620, 42621, 42625, 42626, 42628, 42630, 42631, 42632, 42634, 42635, 42636, 42637, 42639, 42640, 42642, 42644, 42645, 42647, 42650, 42653, 42654, 42657, 42658, 42661, 42663, 42671, 42675, 42680, 42682, 42683, 42685, 42686, 42687, 42690, 42691, 42693, 42694, 42695, 42696, 42700, 42703, 42706, 42707, 42708, 42709, 42710, 42711, 42712, 42713, 42714, 42716, 42721, 42722, 42724, 42725, 42726, 42727, 42729, 42732, 42733, 42737, 42738, 42739, 42740, 42741, 42743, 42745, 42746, 42747, 42751, 42752, 42753, 42755, 42756, 42757, 42758, 42759, 42761, 42766, 42768, 42769, 42781, 42782, 42784, 42785, 42789, 42790, 42795, 42796, 42804, 42805, 42806, 42808, 42809, 42815, 42817, 42819, 42820, 42823, 42825, 42826, 42827, 42828, 42833, 42834, 42836, 42837, 42838, 42839, 42841, 42842, 42845, 42847, 42848, 42849, 42851, 42852, 42857, 42870, 42876, 42878, 42880, 42881, 42882, 42883, 42886, 42891, 42892, 42896, 42897, 42901, 42902, 42903, 42905, 42907, 42911, 42913, 42914, 42915, 42916, 42917, 42920, 42922, 42924, 42927, 42928, 42929, 42932, 42936, 42944, 42947, 42948, 42951, 42953, 42960, 42961, 42962, 42964, 42965, 42967, 42969, 42970, 42971, 42972, 42974, 42975, 42976, 42977, 42978, 42979, 42980, 42982, 42983, 42984, 42986, 42987, 42989, 42990, 42992, 42994, 42995, 42998, 42999, 43004, 43005, 43006, 43009, 43010, 43011, 43012, 43013, 43015, 43016, 43017, 43019, 43020, 43021, 43022, 43023, 43027, 43028, 43029, 43030, 43032, 43033, 43036, 43038, 43039, 43040, 43042, 43043, 43044, 43045, 43046, 43048, 43049, 43051, 43053, 43055, 43060, 43062, 43063, 43066, 43068, 43069, 43070, 43071, 43072, 43074, 43077, 43079, 43081, 43082, 43084, 43085, 43087, 43088, 43090, 43092, 43093, 43096, 43097, 43099, 43101, 43103, 43106, 43107, 43110, 43115, 43116, 43119, 43121, 43122, 43123, 43124, 43125, 43126, 43127, 43128, 43132, 43137, 43141, 43142, 43147, 43148, 43151, 43153, 43154, 43155, 43159, 43160, 43161, 43162, 43163, 43165, 43166, 43167, 43168, 43171, 43174, 43175, 43176, 43178, 43179, 43180, 43181, 43184, 43185, 43187, 43188, 43190, 43191, 43193, 43198, 43199, 43200, 43202, 43204, 43205, 43206, 43207, 43210, 43211, 43213, 43214, 43218, 43220, 43221, 43223, 43224, 43225, 43226, 43227, 43229, 43230, 43231, 43235, 43236, 43237, 43238, 43239, 43240, 43244, 43245, 43246, 43249, 43250, 43251, 43256, 43257, 43258, 43261, 43262, 43264, 43265, 43267, 43269, 43273, 43274, 43276, 43277, 43279, 43280, 43281, 43282, 43284, 43285, 43286, 43287, 43289, 43291, 43292, 43293, 43294, 43295, 43296, 43298, 43299, 43302, 43305, 43306, 43307, 43309, 43310, 43312, 43313, 43314, 43315, 43319, 43321, 43323, 43325, 43326, 43327, 43328, 43331, 43332, 43333, 43334, 43336, 43337, 43338, 43339, 43340, 43342, 43343, 43344, 43345, 43346, 43347, 43348, 43350, 43351, 43352, 43353, 43354, 43355, 43358, 43361, 43362, 43363, 43364, 43365, 43366, 43368, 43369, 43370, 43376, 43378, 43379, 43382, 43386, 43388, 43389, 43390, 43391, 43392, 43393, 43394, 43395, 43398, 43399, 43400, 43403, 43407, 43408, 43410, 43411, 43414, 43416, 43419, 43421, 43422, 43428, 43429, 43430, 43431, 43433, 43435, 43436, 43438, 43439, 43441, 43444, 43446, 43448, 43450, 43452, 43454, 43455, 43457, 43458, 43460, 43461, 43462, 43464, 43465, 43467, 43468, 43469, 43470, 43471, 43472, 43473, 43474, 43475, 43476, 43477, 43478, 43479, 43481, 43482, 43483, 43486, 43488, 43489, 43490, 43494, 43495, 43496, 43499, 43503, 43504, 43505, 43507, 43508, 43509, 43511, 43513, 43516, 43517, 43519, 43520, 43522, 43524, 43525, 43526, 43527, 43528, 43530, 43531, 43533, 43536, 43537, 43539, 43542, 43543, 43544, 43545, 43550, 43551, 43552, 43554, 43556, 43557, 43558, 43559, 43560, 43561, 43563, 43564, 43565, 43566, 43568, 43570, 43572, 43573, 43575, 43577, 43578, 43583, 43584, 43586, 43593, 43595, 43596, 43597, 43599, 43600, 43601, 43603, 43605, 43606, 43607, 43609, 43611, 43612, 43618, 43619, 43620, 43624, 43626, 43627, 43631, 43634, 43636, 43639, 43640, 43641, 43643, 43645, 43646, 43648, 43649, 43650, 43651, 43652, 43656, 43657, 43658, 43659, 43660, 43663, 43664, 43665, 43666, 43667, 43668, 43675, 43678, 43679, 43681, 43684, 43685, 43686, 43687, 43689, 43690, 43691, 43693, 43694, 43695, 43697, 43698, 43700, 43701, 43702, 43705, 43710, 43712, 43715, 43716, 43717, 43718, 43721, 43727, 43728, 43729, 43732, 43733, 43734, 43735, 43738, 43739, 43740, 43741, 43743, 43747, 43748, 43750, 43751, 43752, 43755, 43756, 43757, 43759, 43764, 43767, 43768, 43770, 43771, 43772, 43773, 43778, 43779, 43783, 43784, 43785, 43786, 43787, 43789, 43790, 43791, 43792, 43793, 43795, 43797, 43800, 43802, 43805, 43806, 43807, 43808, 43812, 43813, 43814, 43815, 43818, 43819, 43820, 43821, 43822, 43823, 43824, 43826, 43827, 43828, 43829, 43831, 43833, 43834, 43835, 43837, 43838, 43840, 43841, 43842, 43843, 43845, 43848, 43849, 43850, 43854, 43860, 43861, 43862, 43864, 43865, 43866, 43867, 43868, 43869, 43870, 43873, 43876, 43877, 43878, 43879, 43881, 43883, 43884, 43885, 43888, 43889, 43890, 43891, 43892, 43893, 43894, 43896, 43897, 43898, 43900, 43901, 43902, 43903, 43905, 43906, 43907, 43911, 43912, 43913, 43920, 43922, 43924, 43926, 43928, 43929, 43936, 43937, 43939, 43942, 43944, 43945, 43946, 43948, 43949, 43950, 43952, 43955, 43956, 43957, 43958, 43959, 43960, 43962, 43963, 43964, 43965, 43966, 43967, 43968, 43971, 43973, 43974, 43975, 43977, 43983, 43984, 43985, 43990, 43993, 43994, 43997, 43998, 43999, 44001, 44005, 44006, 44009, 44012, 44013, 44014, 44015, 44017, 44023, 44024, 44026, 44027, 44028, 44029, 44031, 44032, 44034, 44035, 44037, 44038, 44039, 44041, 44042, 44044, 44046, 44047, 44048, 44052, 44054, 44056, 44059, 44060, 44070, 44071, 44072, 44073, 44077, 44078, 44080, 44081, 44086, 44087, 44097, 44100, 44104, 44106, 44107, 44109, 44110, 44113, 44115, 44117, 44121, 44122, 44125, 44126, 44130, 44131, 44137, 44138, 44139, 44141, 44144, 44145, 44146, 44147, 44148, 44149, 44152, 44155, 44156, 44158, 44160, 44162, 44164, 44165, 44166, 44169, 44170, 44171, 44172, 44175, 44179, 44180, 44182, 44184, 44186, 44187, 44189, 44191, 44192, 44193, 44194, 44196, 44198, 44200, 44201, 44203, 44204, 44209, 44210, 44211, 44212, 44213, 44214, 44215, 44216, 44219, 44221, 44223, 44225, 44226, 44227, 44228, 44230, 44231, 44232, 44233, 44237, 44238, 44243, 44244, 44245, 44247, 44248, 44250, 44252, 44254, 44256, 44257, 44261, 44263, 44264, 44265, 44266, 44268, 44274, 44275, 44276, 44277, 44279, 44280, 44282, 44284, 44290, 44291, 44292, 44301, 44302, 44303, 44304, 44305, 44307, 44309, 44310, 44311, 44312, 44316, 44317, 44319, 44320, 44321, 44322, 44323, 44324, 44325, 44327, 44328, 44330, 44331, 44334, 44336, 44337, 44338, 44344, 44346, 44349, 44350, 44351, 44352, 44355, 44357, 44358, 44359, 44363, 44368, 44369, 44372, 44373, 44374, 44375, 44377, 44379, 44388, 44392, 44393, 44399, 44401, 44403, 44405, 44407, 44408, 44409, 44411, 44414, 44415, 44416, 44420, 44422, 44427, 44428, 44430, 44431, 44434, 44435, 44437, 44445, 44448, 44449, 44450, 44451, 44452, 44455, 44456, 44457, 44459, 44463, 44464, 44466, 44467, 44469, 44471, 44473, 44475, 44477, 44482, 44484, 44486, 44489, 44490, 44492, 44493, 44494, 44496, 44499, 44501, 44502, 44503, 44507, 44508, 44510, 44511, 44513, 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45338, 45339, 45340, 45342, 45343, 45344, 45345, 45347, 45348, 45349, 45350, 45351, 45352, 45353, 45354, 45355, 45356, 45357, 45358, 45359, 45360, 45361, 45362, 45363, 45364, 45365, 45367, 45368, 45369, 45370, 45371, 45372, 45373, 45374, 45375, 45377, 45378, 45379, 45380, 45381, 45406, 45407, 45408, 45409, 45410, 45411, 45412, 45413, 45414, 45415, 45416, 45417, 45418, 45419, 45420, 45424, 45425, 45426, 45427, 45428, 45431, 45438, 45439, 45440, 45461, 45462, 45463, 45464, 45466, 45467, 45468, 45469, 45472, 45473, 45474, 45479, 45482, 45484, 45493, 45499, 45500, 50002, 50004, 50005, 50006, 50007, 50008, 50010, 50011, 50013, 50014, 50015, 50016, 50017, 50018, 50020, 50024, 50025, 50027, 50029, 50030, 50031, 50034, 50035, 50036, 50037, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50049, 50051, 50052, 50054, 50056, 50059, 50061, 50062, 50063, 50064, 50065, 50067, 50068, 50071, 50072, 50073, 50074, 50078, 50079, 50085, 50087, 50088, 50089, 50091, 50092, 50094, 50096, 50097, 50098, 50100, 50102, 50103, 50104, 50105, 50106, 50107, 50108, 50109, 50110, 50111, 50112, 50114, 50115, 50116, 50118, 50120, 50121, 50123, 50124, 50127, 50128, 50131, 50132, 50133, 50134, 50135, 50140, 50142, 50143, 50144, 50145, 50146, 50147, 50151, 50154, 50155, 50159, 50160, 50163, 50164, 50166, 50167, 50168, 50169, 50170, 50174, 50178, 50179, 50180, 50181, 50185, 50186, 50187, 50188, 50189, 50192, 50193, 50194, 50195, 50199, 50200, 50201, 50202, 50203, 50206, 50207, 50208, 50209, 50210, 50211, 50214, 50216, 50218, 50219, 50221, 50223, 50224, 50225, 50226, 50229, 50230, 50231, 50232, 50234, 50235, 50236, 50237, 50239, 50240, 50241, 50242, 50243, 50247, 50250, 50251, 50252, 50253, 50255, 50256, 50257, 50259, 50260, 50263, 50266, 50267, 50268, 50269, 50274, 50280, 50281, 50282, 50284, 50286, 50287, 50289, 50290, 50292, 50293, 50294, 50296, 50297, 50298, 50300, 50301, 50302, 50304, 50305, 50306, 50307, 50309, 50310, 50313, 50314, 50316, 50317, 50320, 50321, 50326, 50327, 50328, 50329, 50332, 50333, 50336, 50338, 50339, 50340, 50342, 50344, 50347, 50348, 50353, 50358, 50363, 50365, 50366, 50367, 50368, 50370, 50372, 50375, 50378, 50382, 50383, 50384, 50385, 50389, 50390, 50391, 50392, 50393, 50394, 50395, 50396, 50401, 50402, 50404, 50405, 50406, 50407, 50411, 50413, 50417, 50418, 50422, 50423, 50426, 50429, 50430, 50431, 50437, 50438, 50440, 50441, 50443, 50446, 50447, 50454, 50456, 50457, 50458, 50459, 50464, 50465, 50468, 50469, 50473, 50474, 50478, 50480, 50481, 50483, 50484, 50485, 50486, 50489, 50491, 50492, 50495, 50496, 50497, 50498, 50499, 50507, 50509, 50510, 50511, 50512, 50517, 50518, 50520, 50521, 50522, 50523, 50524, 50525, 50527, 50531, 50533, 50534, 50535, 50536, 50537, 50541, 50543, 50544, 50546, 50548, 50549, 50550, 50551, 50552, 50553, 50554, 50555, 50556, 50558, 50559, 50560, 50562, 50563, 50565, 50566, 50567, 50568, 50569, 50570, 50571, 50572, 50573, 50574, 50577, 50578, 50579, 50580, 50581, 50584, 50585, 50586, 50587, 50591, 50592, 50593, 50594, 50595, 50596, 50597, 50598, 50599, 50601, 50602, 50605, 50606, 50607, 50609, 50610, 50611, 50614, 50615, 50616, 50617, 50618, 50620, 50621, 50622, 50623, 50624, 50625, 50629, 50630, 50631, 50634, 50635, 50636, 50639, 50640, 50641, 50642, 50643, 50644, 50645, 50646, 50647, 50648, 50649, 50651, 50652, 50653, 50656, 50657, 50659, 50660, 50661, 50662, 50663, 50664, 50665, 50666, 50670, 50671, 50672, 50673, 50674, 50676, 50677, 50678, 50679, 50680, 50681, 50682, 50683, 50684, 50685, 50686, 50687, 50689, 50690, 50691, 50694, 50695, 50697, 50698, 50699, 50700, 50701, 50702, 50703, 50704, 50705, 50708, 50709, 50711, 50714, 50715, 50716, 50717, 50718, 50719, 50721, 50722, 50723, 50724, 50726, 50727, 50728, 50730, 50732, 50733, 50734, 50735, 50736, 50738, 50739, 50740, 50741, 50742, 50744, 50745, 50747, 50748, 50749, 50750, 50752, 50753, 50754, 50755, 50757, 50758, 50759, 50760, 50762, 50763, 50764, 50765, 50769, 50770, 50771, 50775, 50776, 50777, 50778, 50779, 50780, 50781, 50784, 50785, 50786, 50788, 50790, 50793, 50794, 50795, 50796, 50797, 50798, 50799, 50800, 50802, 50803, 50804, 50805, 50808, 50810, 50812, 50814, 50817, 50819, 50822, 50823, 50827, 50828, 50829, 50832, 50834, 50835, 50836, 50839, 50843, 50845, 50846, 50847, 50848, 50849, 50850, 50851, 50852, 50853, 50854, 50855, 50856, 50858, 50862, 50864, 50865, 50866, 50867, 50868, 50870, 50871, 50872, 50873, 50874, 50876, 50877, 50878, 50879, 50880, 50881, 50883, 50884, 50885, 50887, 50888, 50890, 50891, 50892, 50893, 50894, 50895, 50897, 50902, 50905, 50906, 50907, 50909, 50913, 50914, 50916, 50918, 50919, 50920, 50921, 50922, 50923, 50924, 50925, 50926, 544000, 544002, 544019, 544033, 544043, 544049, 544050, 544051, 544053, 544055, 544065, 544069, 544108, 544111, 544112, 544127, 544134, 544135, 544159, 544167, 544168, 544176, 544177, 544185, 544197, 544206, 544229, 544236, 544239, 544241, 544253, 544278, 544286, 544289, 544293, 544295, 544296, 544308, 544314, 544332, 544335, 544340, 544345, 544354, 544371, 544376, 544386, 544389, 544398, 544412, 544413, 544425, 544432, 544433, 544436, 544438, 544443, 544454, 544458, 544470, 544472, 544476, 544479, 544483, 544488, 544498, 544524, 544528, 544533, 544541, 544542, 544550, 544551, 544554, 544555, 544560, 544562, 544569, 544582, 544587, 544588, 544596, 544598, 544605, 544639, 544646, 544669, 544672, 544676, 544678, 544729, 544747, 544751, 544778, 544782, 544784, 544787, 544793, 544802, 544833, 544850, 544855, 544876, 544877, 544879, 544913, 544916, 544936, 544943, 544953, 544977, 544979, 544981, 544982, 545000, 545010, 545012, 545022, 545026, 545043, 545056, 545057, 545058, 545059, 545070, 545102, 545106, 545109, 545124, 545133, 545141, 545143, 545144, 545145, 545148, 545183, 545187, 545197, 545199, 545207, 545219, 545222, 545229, 545232, 545237, 545244, 545251, 545262, 545263, 545266, 545268, 545270, 545271, 545272, 545273, 545274, 545275, 545277, 545278, 545279, 545280, 545282, 545283, 545284, 545287, 545291, 545292, 545293, 545294, 545295, 545296, 545298, 545299, 545303, 545304, 545308, 545309, 545311, 545312, 545313, 545314, 545316, 545319, 以上3119台 （平成１６年５月３１日現在）
輸入販売業者の氏名 ： バクスター株式会社 営業所の名称 ： バクスター株式会社 営業所の所在地 ： 東京都千代田区六番町４番地 英全ビルヂング 営業所の業許可番号 ： １３ＢＹ０３２１ 製造業者の氏名 ： バクスター株式会社 営業所の名称 ： バクスター株式会社 東京技術サービスセンター 営業所の所在地 ： 東京都大田区東海４-１０-８ 株式会社ダイトーコーポレーション大井物流センター内 営業所の業許可番号 ： １３ＢＺ６０８３
ホームＡＰＤシステムゆめは、日中貯留していた液を最初に排液する際（初回排液）、 十分に排液が完了し腹腔内が空になったことを確認したのち、１回目の注液に移るための安全機構が付加されています。 初回排液の流速が基準値以下に落ちたことを検知すると同時に、 予め設定された「初回排液の限度」（例：○○○○ｍＬ）がすでに排液されていることを計算し、 両方の条件が満たされている場合にのみ１回目の注液に移るプログラムとなっています。 「初回排液の限度」は、治療開始前に「設定なし」もしくは０ｍＬ〜３５００ｍＬの値から選択設定できます。 日中貯留している状態から治療開始の場合、通常、この一方の安全機構を無効とする「設定なし」は使用されず、 出荷時の設定も１４００ｍＬとなっています。 回収対象となったバージョン８.５および８．６ソフトウェア搭載機では、さらに安全機構が追加され、 この「初回排液の限度」が「設定なし」あるいは「０ｍＬ」など極端に低い値で選択された場合、 治療開始ポタンが押された直後、本当に治療を開始してよいか再確認のメッセージが表示され、一時停止します。 また、そこで、選択された値を一時的に変更して（例：設定なし→１０００ｍＬ）、治療を継続する機能があります。 今回確認された不具合は、その一時変更の機能を使用して、「設定なし」からある値（○○○○ｍＬ）に変更しても、 その値が機械内部で有効とならず、「設定なし」の状態が継続されるため、 初回排液量が限度値に達しない場合でもアラームが作動せずに、１回目の注液に移ることがあります。 そのため、腹腔内に液が残っていた場合、過注液となる可能性があります。 なお、治療開始前にメニュー画面で設定された場合、もしくは一時停止時に「○○○○ｍＬ」からの 変更については（例：０ｍＬ→１０００ｍＬ）、正常に動作します。 そのため、医療機関に対して、今後は、治療開始前の設定で「初回排液の限度」に「設定なし」は選択せず、 適切な限度値（０ｍＬ〜３５００ｍＬ）の設定で使用するように情報提供を行います。
過注液が発生した場合には、腹部膨満感、腹痛、息切れなどの症状があらわれることがあります。 余分に注液された透析液を排液することにより、症状は改善されます。 なお、このソフトウェアの不具合を原因とする健康被害は、現在まで国内外ともに報告されていません。
平成１６年５月２６日（情報提供の開始日）
腹膜透析の治療時に、透析液の注液、貯留、排液を自動制御するため使用します。
納入しました医療機関は全て弊社で把握しております。カスタマーレターを対象医療機関に配布説明するとともに、 修正ソフトウェアの開発完了後、改修を全数実施いたします。
連絡先 ： バクスター株式会社 東京都千代田区六番町４番地 英全ビルヂング 担当者名 ： 品質保証部 藤田正彦 電話番号 ： ０３−５２１３−５１４０ ＦＡＸ番号： ０３−５２１３−５１４１