平成２０年３月１６日作成
平成２１年４月１日訂正（＊）
医療機器回収の概要（クラスII）

1. 一般的名称及び販売名（１）一般的名称：二相式気道陽圧ユニット
販売名：在宅用人工呼吸器 クリーンエア ＶＳ ＳＥＲＥＮＡ（２）一般的名称：成人用人工呼吸器
販売名：人工呼吸器クリーンエア ＶＳ

ＩＮＴＥＧＲＡ（３）一般的名称：成人用人工呼吸器
販売名：人工呼吸器クリーンエア ＶＳ

ＵＬＴＲＡ

2. 対象ロット、数量及び出荷時期(1)在宅用人工呼吸器 クリーンエア ＶＳ ＳＥＲＥＮＡ
製造番号（＊）：
S0503189, S0505083, S0505093, S0505099, S0505100, S0505107, S0506078, S0506084,
S0506091, S0506092, S0506093, S0506094, S0506095, S0506096, S0506097, S0507034,
S0507036, S0507037, S0507063, S0507067, S0507068, S0507112, S0507113, S0507115,
S0507118, S0507119, S0508004, S0508006, S0508010, S0508011, S0508012, S0508044,
S0508045, S0508046, S0508047, S0508048, S0508050, S0508052, S0508055, S0508056,
S0508058, S0508061, S0508072, S0508073, S0508076, S0508077, S0508078, S0508079,
S0508080, S0508084, S0509023, S0509024, S0509025, S0509026, S0509027, S0509028,
S0509031, S0509032, S0509033, S0509037, S0509038, S0509042, S0509043, S0510022,
S0510027, S0510028, S0510029, S0510030, S0510032, S0510033, S0510034, S0510035,
S0510036, S0510037, S0510038, S0510039, S0510040, S0510041, S0510042, S0510044,
S0510045, S0511065, S0511079, S0511100, S0511105, S0511112, S0511123, S0511127,
S0511128, S0511142, S0511149, S0511151, S0512011, S0512017, S0512019, S0512020,
S0512023, S0512024, S0512025, S0512026, S0601042, S0601043, S0601044, S0601045,
S0601046, S0601047, S0601048, S0601049, S0601050, S0601061, S0601062, S0601063,
S0601064, S0601066, S0601067, S0601068, S0601069, S0601070, S0603033, S0603034,
S0603038, S0603051, S0603052, S0603053, S0603054, S0603055, S0603056, S0603057,
S0603058, S0603061, S0603062, S0603063, S0603064, S0603065, S0603066, S0603067,
S0603068, S0603069, S0603073, S0603074, S0603083, S0603084, S0603085, S0603088,
S0603089, S0604043, S0604044, S0604049, S0606031, S0606033, S0606037, S0606042,
S0606043, S0606048, S0606049, S0606051, S0606052, S0606053, S0606055, S0606056,

S0606057, S0606058, S0606059, S0606060, S0606061, S0606062, S0606063, S0606064,
S0606066, S0606067, S0606068, S0606069, S0606070, S0606071, S0606072, S0606073,
S0606076, S0606078, S0606079, S0606085, S0606086, S0606091, S0606092, S0606093,
S0606095, S0606096, S0606099, S0607021, S0607054, S0607056, S0607058, S0607059,
S0607080, S0607081, S0607084, S0607085, S0607086, S0607090, S0607092, S0608071,
S0608072, S0608073, S0608074, S0608075, S0608076, S0608078, S0608079, S0608080,
S0608084, S0610003, S0610011, S0610030, S0610071, S0611001, S0611002, S0611003,
S0611004, S0611005, S0611006, S0611007, S0611008, S0611009, S0611077, S0611106,
S0611107, S0611109, S0612111, S0612112, S0612113, S0612115, S0612117, S0612119,
S0612120, S0612121, S0612122, S0612123, S0612124, S0612125, S0612127, S0612131,
S0612133, S0612135, S0612136, S0612137, S0612138, S0612139, S0612140, S0612149,
S0612159, S0612171, S0612172, S0612173, S0612174, S0612175, S0612176, S0612177,
S0612178, S0612183, S0612184, S0612189, S0612199, S0701016, S0701044, S0701056,
S0701057, S0701058, S0701059, S0701060, S0701061, S0701062, S0701063, S0701064,
S0701065, S0701071, S0701072, S0701076, S0701077, S0701078, S0701080, S0701086,
S0701087, S0701088, S0701089, S0701090, S0701091, S0701093, S0701094, S0701098,
S0701099, S0701101, S0701114, S0701126, S0701128, S0701135, VS0603059, VS0606098,
VS0612179, VS0701045, VS0701127, VS0701130, VS0701132, VS0701133, VS0701134,
VS0705077, VS0705082, VS0705085, VS0705086, VS0705087, VS0707501, VS0707502,
VS0707503, VS0707504, VS0707505, VS0707506, VS0707507, VS0707508, VS0707509,
VS0707510, VS0708501, VS0708502, VS0708503, VS0708504, VS0708505, VS0708506,
VS0708507, VS0708508, VS0708509, VS0708510, VS0708511, VS0708512, VS0708513,
VS0708514, VS0708515, VS0708516, VS0708517, VS0708518, VS0708519, VS0708520,
VS0709501, VS0709502, VS0709503, VS0709504, VS0709505, VS0709506, VS0709507,
VS0709508, VS0709509, VS0709510, VS0709511, VS0709512, VS0709513, VS0709514,
VS0709515, VS0709516, VS0709517, VS0709518, VS0709519, VS0709520, VS0709521,
VS0709522, VS0709523, VS0709524, VS0709525, VS0709526, VS0709527, VS0709528,
VS0709529, VS0709530, VS0709531, VS0709532, VS0709533, VS0709534, VS0709535,
VS0709536, VS0709537, VS0709538, VS0709539, VS0709540, VS0711501, VS0711502,
VS0711503, VS0711504, VS0711505, VS0711506, VS0711507, VS0711508, VS0711509,
VS0711510, VS0711511, VS0711512, VS0711513, VS0711514, VS0711515, VS0711516,
VS0711517, VS0711518, VS0711519, VS0711520, VS0711531, VS0711532, VS0711533,
VS0711534, VS0711535, VS0711536, VS0711537, VS0711538, VS0711539, VS0711540,
VS0711541, VS0711542, VS0711543, VS0711544, VS0711545, VS0711546, VS0711547,
VS0711548, VS0711549, VS0711550, VS0712543, VS0712544, VS0712545, VS0712546,
VS0712548, VS0712549, VS0712550, VS0712551, VS0712552, VS0803511, VS0803512,
VS0803513, VS0803514, VS0803515, VS0803516, VS0803517, VS0803518, VS0803519,
VS0803520, VS0803521, VS0803522, VS0803523, VS0803524, VS0803525, VS0803526,
VS0803527, VS0803528, VS0803529, VS0803530, VS0803531, VS0803532, VS0803533,
VS0803534, VS0803535, VS0803536, VS0803537, VS0803538, VS0803539, VS0803540,
VS0805521, VS0805522, VS0805523, VS0805524, VS0805525, VS0805526, VS0805527,
VS0805528, VS0805529, VS0805530, VS0805531, VS0805532, VS0805533, VS0805534,
VS0805535, VS0805536, VS0805537, VS0805538, VS0805539, VS0805540, VS0806561,

VS0806562, VS0806563, VS0806564, VS0806565, VS0806566, VS0806567, VS0806568,
VS0806569, VS0806570, VS0807501, VS0807502, VS0807503, VS0807504, VS0807505,
VS0807506, VS0807507, VS0807508, VS0807509, VS0807510, VS0810531, VS0810532,
VS0810533, VS0810534, VS0810535, VS0810536, VS0810537, VS0810538, VS0810539,
VS0810540, VS0810541, VS0810542, VS0810543, VS0810544, VS0810545, VS0810546,
VS0810547, VS0810548, VS0810549, VS0810550, VS0810551, VS0810552, VS0810553,
VS0810554, VS0810555, VS0810556, VS0810557, VS0810558, VS0810559, VS0810560,
VS0810561, VS0810562, VS0810563, VS0810564, VS0810565, VS0810566, VS0810567,
VS0810568, VS0810569, VS0810570, VS0810571, VS0810572, VS0810573, VS0810574,
VS0810575, VS0810576, VS0810577, VS0810578, VS0810579, VS0810580, VS0810581,
VS0810582, VS0810583, VS0810584, VS0810585, VS0810586, VS0810587, VS0810588,
VS0810589, VS0810590, VS0810591, VS0810592, VS0810593, VS0810594, VS0810595,
VS0810596, VS0810597, VS0810598, VS0810599, VS0810600, VS0810601, VS0810602,
VS0810603, VS0810604, VS0810605, VS0810606, VS0810607, VS0810608, VS0810609,
VS0810610, VS0811501, VS0811502, VS0811503, VS0811504, VS0811505, VS0811506,
VS0811507, VS0811508, VS0811509, VS0811510, VS0811526, VS0811527, VS0811528,
VS0811529, VS0811530, VS0811531, VS0811532, VS0811533, VS0811534
出荷数量 ：５９６台（＊）
出荷時期：平成１７年６月１０日～平成２１年１月１５日(2) 人工呼吸器 クリーンエア ＶＳ ＩＮＴＥＧＲＡ
製造番号（＊）：
I0512255, I0512261, I0512343, I0512357, I0601019, I0602110, I0602185, I0602189,
I0603029, I0604105, I0604110, I0604115, I0604122, I0604128, I0605005, I0605006,
I0605008, I0605009, I0605010, I0605011, I0605012, I0605013, I0605021, I0605022,
I0605026, I0605027, I0605034, I0605035, I0605036, I0605051, I0605052, I0605053,
I0605054, I0605056, I0605059, I0605066, I0605092, I0605133, I0606021, I0606022,
I0606028, I0606052, I0606054, I0606055, I0606056, I0606058, I0606071, I0606074,
I0606076, I0606078, I0606084, I0606087, I0606093, I0606099, I0606101, I0606130,
I0606152, I0606153, I0606155, I0606157, I0607018, I0607121, I0607126, I0607128,
I0607132, I0607143, I0607149, I0607211, I0607212, I0607215, I0607216, I0607218,
I0607220, I0607227, I0607228, I0607248, I0607250, I0607278, I0609040, I0609043,
I0609060, I0609061, I0609064, I0609066, I0609068, I0609069, I0609071, I0609076,
I0609079, I0609083, I0609086, I0609088, I0609089, I0609092, I0609095, I0609097,
I0611006, I0611007, I0611009, I0611010, I0611014, I0611017, I0611022, I0611023,
I0611027, I0611028, I0611029, I0611031, I0611032, I0611034, I0611035, I0611036,
I0611038, I0611039, I0611061, I0611062, I0611063, I0611066, I0611069, I0611070,
I0611071, I0611072, I0611073, I0611074, I0611075, I0611078, I0611079, I0611081,
I0611082, I0611083, I0611084, I0611085, I0611087, I0611088, I0611089, I0611091,
I0611093, I0611095, I0611096, I0611097, I0611098, I0611099, I0611100, I0611103,
I0611106, I0611107, I0611109, I0611111, I0611112, I0611113, I0611114, I0611115,
I0611116, I0611117, I0611118, I0611119, I0611120, I0611122, I0611124, I0611125,
I0611126, I0611128, I0611130, I0611132, I0611133, I0611134, I0611136, I0611137,

I0611138, I0611142, I0611144, I0611145, I0611146, I0611147, I0611149, I0611150,
I0611156, I0611157, I0611158, I0611160, I0611162, I0611164, I0611165, I0611166,
I0611168, I0611169, I0611170, I0612008, I0612019, I0612043, I0612045, I0612046,
I0612051, I0612060, I0701131, I0701165, I0701168, I0701169, I0701170, I0701171,
I0701172, I0701174, I0701175, I0701201, I0701202, I0701203, VSI0604117, VSI0604120,
VSI0605015, VSI0606032, VSI0609050, VSI0609081, VSI0609098, VSI0611008, VSI0611011,
VSI0611013, VSI0611016, VSI0611018, VSI0611094, VSI0611139, VSI0701204, VSI0701205,
VSI0701206, VSI0701207, VSI0701208, VSI0701209, VSI0701210, VSI0701263, VSI0701265,
VSI0701267, VSI0701271, VSI0701278, VSI0701279, VSI0701284, VSI0701288, VSI0701289,
VSI0701291, VSI0703104, VSI0703105, VSI0703106, VSI0703107, VSI0703108, VSI0703109,
VSI0703110, VSI0703112, VSI0703113, VSI0705179, VSI0705181, VSI0705182, VSI0705183,
VSI0705184, VSI0705185, VSI0705186, VSI0705187, VSI0705188, VSI0705189, VSI0705190,
VSI0705191, VSI0705192, VSI0706541, VSI0706542, VSI0706543, VSI0706544, VSI0706545,
VSI0706546, VSI0706547, VSI0706548, VSI0706549, VSI0706550, VSI0706551, VSI0706552,
VSI0706553, VSI0706554, VSI0706555, VSI0706556, VSI0706557, VSI0706558, VSI0706559,
VSI0706560, VSI0707501, VSI0707502, VSI0707503, VSI0707504, VSI0707505, VSI0707506,
VSI0707507, VSI0707508, VSI0707509, VSI0707510, VSI0708501, VSI0708502, VSI0708503,
VSI0708504, VSI0708505, VSI0708506, VSI0708507, VSI0708508, VSI0708509, VSI0708510,
VSI0708511, VSI0708512, VSI0708513, VSI0708514, VSI0708515, VSI0708516, VSI0708517,
VSI0708518, VSI0708519, VSI0708520, VSI0708521, VSI0708522, VSI0708523, VSI0708524,
VSI0708525, VSI0708526, VSI0708527, VSI0708528, VSI0708529, VSI0708530, VSI0709501,
VSI0709502, VSI0709503, VSI0709504, VSI0709505, VSI0709506, VSI0709507, VSI0709508,
VSI0709509, VSI0709510, VSI0709511, VSI0709512, VSI0709513, VSI0709514, VSI0709515,
VSI0709516, VSI0709517, VSI0709518, VSI0709519, VSI0709520, VSI0709521, VSI0709522,
VSI0709523, VSI0709524, VSI0709525, VSI0709526, VSI0709527, VSI0709528, VSI0709529,
VSI0709530, VSI0709531, VSI0709532, VSI0709533, VSI0709534, VSI0709535, VSI0709536,
VSI0709537, VSI0709538, VSI0709539, VSI0709540, VSI0709541, VSI0709542, VSI0709543,
VSI0709544, VSI0709545, VSI0709546, VSI0709547, VSI0709548, VSI0709550, VSI0709551,
VSI0709552, VSI0709553, VSI0709554, VSI0709555, VSI0709556, VSI0709557, VSI0709558,
VSI0709559, VSI0709560, VSI0710531, VSI0710532, VSI0710533, VSI0710534, VSI0710535,
VSI0710536, VSI0710537, VSI0710538, VSI0710539, VSI0710540, VSI0710541, VSI0710542,
VSI0710543, VSI0710544, VSI0710545, VSI0710546, VSI0710547, VSI0710548, VSI0710549,
VSI0710550, VSI0710551, VSI0710552, VSI0710553, VSI0710554, VSI0710555, VSI0710556,
VSI0710557, VSI0710558, VSI0710559, VSI0710560, VSI0710608, VSI0710609, VSI0710610,
VSI0710611, VSI0710612, VSI0710613, VSI0710614, VSI0710615, VSI0710616, VSI0710617,
VSI0710618, VSI0710619, VSI0710620, VSI0710621, VSI0710622, VSI0710623, VSI0710624,
VSI0710625, VSI0710626, VSI0710627, VSI0710628, VSI0710629, VSI0710630, VSI0710631,
VSI0710634, VSI0710635, VSI0710636, VSI0710637, VSI0803553, VSI0803554, VSI0803555,
VSI0803556, VSI0803557, VSI0803558, VSI0803559, VSI0803560, VSI0803561, VSI0803562,
VSI0803564, VSI0803565, VSI0803566, VSI0803567, VSI0803568, VSI0803569, VSI0803570,
VSI0803571, VSI0803572, VSI0803583, VSI0803584, VSI0803585, VSI0803586, VSI0803587,
VSI0803588, VSI0803589, VSI0803590, VSI0803591, VSI0803592, VSI0804606, VSI0804607,
VSI0804608, VSI0804609, VSI0804611, VSI0804612, VSI0804614, VSI0804615, VSI0804616,

VSI0804617, VSI0804618, VSI0804619, VSI0804620, VSI0804621, VSI0804622, VSI0804623,
VSI0804624, VSI0804625, VSI0804626, VSI0804627, VSI0804629, VSI0804630, VSI0804631,
VSI0804634, VSI0804635, VSI0804781, VSI0804782, VSI0804783, VSI0804784, VSI0804785,
VSI0804786, VSI0804787, VSI0804788, VSI0804789, VSI0804790, VSI0804791, VSI0804792,
VSI0804793, VSI0804794, VSI0804795, VSI0804796, VSI0804797, VSI0804798, VSI0804799,
VSI0804800, VSI0805566, VSI0805567, VSI0805568, VSI0805569, VSI0805570, VSI0805571,
VSI0805572, VSI0805574, VSI0805575, VSI0805576, VSI0805577, VSI0805578, VSI0805579,
VSI0805581, VSI0805582, VSI0805583, VSI0805584, VSI0805585, VSI0805586, VSI0805587,
VSI0805588, VSI0805589, VSI0805590, VSI0805591, VSI0805592, VSI0805593, VSI0805594,
VSI0805595, VSI0806501, VSI0806502, VSI0806503, VSI0806504, VSI0806505, VSI0806506,
VSI0806507, VSI0806508, VSI0806509, VSI0806510, VSI0806511, VSI0806512, VSI0806513,
VSI0806514, VSI0806515, VSI0806516, VSI0806517, VSI0806518, VSI0806519, VSI0806520,
VSI0806521, VSI0806522, VSI0806523, VSI0806524, VSI0806525, VSI0806526, VSI0806527,
VSI0806528, VSI0806529, VSI0806530, VSI0806640, VSI0806641, VSI0806642, VSI0806643,
VSI0806644, VSI0806645, VSI0806646, VSI0806647, VSI0806648, VSI0806649, VSI0806650,
VSI0806651, VSI0806652, VSI0806653, VSI0806654, VSI0806655, VSI0806656, VSI0806657,
VSI0806658, VSI0806659, VSI0806660, VSI0806662, VSI0806663, VSI0806664, VSI0806665,
VSI0806666, VSI0806667, VSI0806668, VSI0806669, VSI0807574, VSI0807575, VSI0807576,
VSI0807577, VSI0807578, VSI0807580, VSI0807582, VSI0807583, VSI0807585, VSI0807586,
VSI0807588, VSI0807589, VSI0807590, VSI0807591, VSI0807594, VSI0807595, VSI0807599,
VSI0807600, VSI0807601, VSI0810521, VSI0810522, VSI0810524, VSI0810526, VSI0810527,
VSI0810528, VSI0810529, VSI0810530, VSI0810532, VSI0810533, VSI0810540, VSI0810541,
VSI0810542, VSI0810543, VSI0810544, VSI0810545, VSI0810546, VSI0810547, VSI0810548,
VSI0810549, VSI0810550, VSI0810551, VSI0810552, VSI0810553, VSI0810554, VSI0810555,
VSI0810556, VSI0810557, VSI0810559, VSI0810560, VSI0810561, VSI0810562, VSI0810563,
VSI0810564, VSI0810565, VSI0810566, VSI0810569, VSI0811501, VSI0811502, VSI0811503,
VSI0811504, VSI0811505, VSI0811506, VSI0811507, VSI0811508, VSI0811509, VSI0811510,
VSI0811511, VSI0811512, VSI0811513, VSI0811514, VSI0811515, VSI0811516, VSI0811517,
VSI0811518, VSI0811519, VSI0811520, VSI0811521, VSI0811522, VSI0811523, VSI0811524,
VSI0811525, VSI0811526, VSI0811527, VSI0811528, VSI0811529, VSI0811530, VSI0811531,
VSI0811532, VSI0811533, VSI0811534, VSI0811535, VSI0811536, VSI0811537, VSI0811538,
VSI0811539, VSI0811540, VSI0811541, VSI0811542, VSI0811543, VSI0811544, VSI0811545,
VSI0811546, VSI0811547, VSI0811548, VSI0811549, VSI0811550, VSI0811551, VSI0811552,
VSI0811553, VSI0811554, VSI0811555, VSI0811556, VSI0811557, VSI0811558, VSI0811559,
VSI0811560, VSI0811561, VSI0811562, VSI0811563, VSI0811564, VSI0811565, VSI0811566,
VSI0811567, VSI0811568, VSI0811569, VSI0811570, VSI0811571, VSI0811572, VSI0811574,
VSI0811575, VSI0811577, VSI0811580, VSI0811581, VSI0811582, VSI0811583, VSI0811584,
VSI0811586, VSI0811589, VSI0811590, VSI0811591, VSI0811594, VSI0811595, VSI0811597,
VSI0811598, VSI0811600, VSI0811601, VSI0811602, VSI0811603, VSI0811604, VSI0811605,
VSI0811606, VSI0811607, VSI0811608, VSI0811609, VSI0811610, VSI0811611, VSI0811612,
VSI0811613, VSI0811614, VSI0811615, VSI0811616, VSI0811617, VSI0811620, VSI0812505,
VSI0812506, VSI0812507, VSI0812513, VSI0812517, VSI0812518, VSI0812521, VSI0812522,
VSI0812523, VSI0812525, VSI0812526, VSI0812527, VSI0812528, VSI0812529

出荷数量 ：７７４台（＊）
出荷時期：平成１８年３月３１日～平成２１年１月２２日(3) 人工呼吸器 クリーンエア ＶＳ ＵＬＴＲＡ
製造番号（＊）：
U0512297, U0512298, U0601089, U0601221, U0603007, U0603008, U0603009, U0603095,
U0603144, U0603196, U0604071, U0604083, U0605042, U0605063, U0605071, U0605075,
U0605077, U0605106, U0605113, U0605114, U0605124, U0605146, U0605149, U0605160,
U0605206, U0605220, U0605225, U0605230, U0605245, U0605246, U0605248, U0605249,
U0605251, U0605253, U0605281, U0606003, U0606004, U0606005, U0606006, U0606011,
U0606014, U0606016, U0606020, U0606195, U0606205, U0606234, U0606241, U0606242,
U0606248, U0606250, U0606256, U0606261, U0606262, U0607052, U0607217, U0607254,
U0607260, U0607262, U0607266, U0607275, U0607277, U0607279, U0607283, U0607290,
U0607291, U0607299, U0607308, U0607313, U0607319, U0607332, U0607333, U0607339,
U0607350, U0608136, U0608197, U0608207, U0608254, U0608255, U0608257, U0608258,
U0608259, U0608260, U0608262, U0610031, U0610268, U0610332, U0611003, U0611006,
U0611009, U0611013, U0611014, U0611017, U0611018, U0611020, U0611025, U0611033,
U0611039, U0611045, U0611060, U0611061, U0611063, U0611067, U0611071, U0611072,
U0611079, U0611083, U0611085, U0611086, U0611097, U0611115, U0611116, U0611119,
U0611120, U0611274, U0611291, U0611292, U0611294, U0611295, U0611297, U0611299,
U0611300, U0611301, U0611302, U0611303, U0611305, U0611306, U0611307, U0611309,
U0612010, U0612020, U0612021, U0612023, U0612025, U0612026, U0612027, U0612028,
U0612029, U0612030, U0612031, U0612032, U0612033, U0612034, U0612036, U0612037,
U0612038, U0612039, U0612040, U0612041, U0612042, U0612043, U0612044, U0612045,
U0612047, U0612049, U0612050, U0612051, U0612052, U0612053, U0612054, U0612055,
U0612056, U0612057, U0612060, U0612061, U0612062, U0612063, U0612064, U0612065,
U0612066, U0612067, U0612068, U0612069, U0612070, U0612071, U0612072, U0612073,
U0612075, U0612076, U0612077, U0612078, U0612079, U0612080, U0612082, U0612083,
U0612084, U0612085, U0612086, U0612087, U0612089, U0612090, U0612091, U0612093,
U0612099, U0701169, U0701210, U0701217, U0701228, U0701230, U0701232, U0701236,
U0701237, U0701238, U0701239, U0701240, U0701241, U0701242, U0701243, U0701244,
U0701245, U0701246, U0701247, U0701248, U0701250, U0701251, U0701256, U0701257,
U0701259, U0701261, U0701263, U0701265, VSU0606239, VSU0607256, VSU0608266,
VSU0611001, VSU0611026, VSU0611081, VSU0612024, VSU0612035, VSU0612048, VSU0612059,
VSU0612081, VSU0701266, VSU0701267, VSU0701268, VSU0701269, VSU0701270, VSU0701271,
VSU0701272, VSU0701273, VSU0701274, VSU0701275, VSU0701288, VSU0701376, VSU0701377,
VSU0701378, VSU0701379, VSU0701380, VSU0701381, VSU0701382, VSU0701383, VSU0701384,
VSU0701393, VSU0701396, VSU0701397, VSU0701398, VSU0701399, VSU0701400, VSU0701401,
VSU0701402, VSU0701403, VSU0701404, VSU0701405, VSU0701416, VSU0701417, VSU0701418,
VSU0701419, VSU0701420, VSU0701424, VSU0701425, VSU0706101, VSU0706102, VSU0706103,
VSU0706105, VSU0706106, VSU0706108, VSU0706109, VSU0706110, VSU0706111, VSU0706112,
VSU0706113, VSU0706114, VSU0706521, VSU0706522, VSU0706523, VSU0706524, VSU0706525,

VSU0706526, VSU0706527, VSU0706528, VSU0706529, VSU0706530, VSU0706531, VSU0706532,
VSU0706533, VSU0706534, VSU0706535, VSU0706536, VSU0706537, VSU0706538, VSU0706539,
VSU0706540, VSU0707501, VSU0707502, VSU0707503, VSU0707504, VSU0707505, VSU0707506,
VSU0707507, VSU0707508, VSU0707509, VSU0707510, VSU0708501, VSU0708502, VSU0708503,
VSU0708504, VSU0708505, VSU0708506, VSU0708507, VSU0708508, VSU0708509, VSU0708510,
VSU0708511, VSU0708513, VSU0708514, VSU0708515, VSU0708516, VSU0708517, VSU0708518,
VSU0708519, VSU0708520, VSU0708521, VSU0708522, VSU0708523, VSU0708524, VSU0708525,
VSU0708526, VSU0708527, VSU0708528, VSU0708529, VSU0708530, VSU0709501, VSU0709502,
VSU0709503, VSU0709505, VSU0709506, VSU0709507, VSU0709508, VSU0709509, VSU0709510,
VSU0709511, VSU0709512, VSU0709513, VSU0709514, VSU0709515, VSU0709516, VSU0709517,
VSU0709518, VSU0709519, VSU0709520, VSU0709521, VSU0709522, VSU0709523, VSU0709524,
VSU0709525, VSU0709526, VSU0709527, VSU0709528, VSU0709529, VSU0709530, VSU0710501,
VSU0710502, VSU0710503, VSU0710504, VSU0710505, VSU0710506, VSU0710507, VSU0710508,
VSU0710509, VSU0710510, VSU0710511, VSU0710512, VSU0710513, VSU0710514, VSU0710515,
VSU0710516, VSU0710517, VSU0710518, VSU0710519, VSU0710520, VSU0710521, VSU0710522,
VSU0710523, VSU0710524, VSU0710525, VSU0710526, VSU0710527, VSU0710528, VSU0710529,
VSU0710530, VSU0710531, VSU0710532, VSU0710533, VSU0710534, VSU0710535, VSU0710536,
VSU0710537, VSU0710538, VSU0710539, VSU0710540, VSU0710541, VSU0710542, VSU0710543,
VSU0710544, VSU0710545, VSU0710546, VSU0710547, VSU0710548, VSU0710549, VSU0710550,
VSU0710551, VSU0710552, VSU0710553, VSU0710554, VSU0710555, VSU0710556, VSU0710557,
VSU0710558, VSU0710559, VSU0710560, VSU0712551, VSU0712552, VSU0712553, VSU0712554,
VSU0712555, VSU0712556, VSU0712557, VSU0712558, VSU0712559, VSU0712560, VSU0712561,
VSU0712562, VSU0712563, VSU0712564, VSU0712565, VSU0712566, VSU0712567, VSU0712568,
VSU0712569, VSU0712570, VSU0712571, VSU0712572, VSU0712573, VSU0712574, VSU0712575,
VSU0712576, VSU0712577, VSU0712578, VSU0712579, VSU0712580, VSU0802501, VSU0802502,
VSU0802503, VSU0802504, VSU0802505, VSU0802506, VSU0802507, VSU0802508, VSU0803581,
VSU0803582, VSU0803583, VSU0803584, VSU0803585, VSU0803586, VSU0803587, VSU0803588,
VSU0803589, VSU0803590, VSU0803591, VSU0803592, VSU0803593, VSU0803594, VSU0803595,
VSU0803596, VSU0803597, VSU0803598, VSU0803599, VSU0803600, VSU0805598, VSU0805599,
VSU0805600, VSU0805601, VSU0805602, VSU0805603, VSU0805604, VSU0805605, VSU0805606,
VSU0805607, VSU0805608, VSU0805609, VSU0805610, VSU0805611, VSU0805612, VSU0805613,
VSU0805614, VSU0805615, VSU0805616, VSU0805617, VSU0805618, VSU0805619, VSU0805621,
VSU0805622, VSU0805623, VSU0805624, VSU0805625, VSU0805626, VSU0805627, VSU0805641,
VSU0805642, VSU0805643, VSU0805644, VSU0805645, VSU0805646, VSU0805647, VSU0805648,
VSU0805649, VSU0805650, VSU0805651, VSU0805652, VSU0805653, VSU0805654, VSU0805655,
VSU0805656, VSU0805657, VSU0805659, VSU0805660, VSU0805661, VSU0805662, VSU0805663,
VSU0805664, VSU0805665, VSU0805666, VSU0805667, VSU0805668, VSU0805669, VSU0806638,
VSU0806639, VSU0806640, VSU0806641, VSU0806643, VSU0806644, VSU0806645, VSU0806646,
VSU0806647, VSU0806648, VSU0806649, VSU0806650, VSU0806651, VSU0806652, VSU0806653,
VSU0806654, VSU0806656, VSU0806657, VSU0806658, VSU0806659, VSU0806660, VSU0807525,
VSU0807526, VSU0807527, VSU0807528, VSU0807529, VSU0807530, VSU0807531, VSU0807532,
VSU0807533, VSU0807534, VSU0807535, VSU0807536, VSU0807537, VSU0807538, VSU0807540,
VSU0807541, VSU0807542, VSU0807543, VSU0807544, VSU0808592, VSU0808593, VSU0808594,

VSU0808595, VSU0808596, VSU0808597, VSU0808598, VSU0808599, VSU0808600, VSU0808601,
VSU0808602, VSU0808603, VSU0808604, VSU0808605, VSU0808606, VSU0808607, VSU0808609,
VSU0808610, VSU0808612, VSU0808613, VSU0808614, VSU0808616, VSU0808617, VSU0808618,
VSU0808620, VSU0808621, VSU0808622, VSU0808625, VSU0808628, VSU0808630, VSU0808632,
VSU0808633, VSU0808635, VSU0808636, VSU0808639, VSU0808641, VSU0808642, VSU0808643,
VSU0808644, VSU0808645, VSU0808646, VSU0808647, VSU0808648, VSU0808649, VSU0808651,
VSU0808652, VSU0808653, VSU0808654, VSU0808655, VSU0808656, VSU0808657, VSU0808658,
VSU0808659, VSU0808660, VSU0808661, VSU0808662, VSU0808663, VSU0808664, VSU0808665,
VSU0808666, VSU0808667, VSU0808668, VSU0808669, VSU0808670, VSU0810501, VSU0810502,
VSU0810503, VSU0810504, VSU0810505, VSU0810506, VSU0810507, VSU0810508, VSU0810509,
VSU0810510, VSU0810512, VSU0810513, VSU0810514, VSU0810516, VSU0810517, VSU0810519,
VSU0810520, VSU0810521, VSU0810522, VSU0810523, VSU0810524, VSU0810525, VSU0810526,
VSU0810527, VSU0810528, VSU0810529, VSU0810530, VSU0810531, VSU0810532, VSU0810533,
VSU0810534, VSU0810535, VSU0810536, VSU0810537, VSU0810538, VSU0810539, VSU0810540,
VSU0810541, VSU0810542, VSU0810543, VSU0810544, VSU0810545, VSU0810546, VSU0810547,
VSU0810548, VSU0810549, VSU0810550, VSU0810552, VSU0810553, VSU0810554, VSU0810555,
VSU0810556, VSU0810557, VSU0810558, VSU0810559, VSU0810561, VSU0810562, VSU0810563,
VSU0810565, VSU0810566, VSU0810567, VSU0810568, VSU0810569, VSU0810570, VSU0810571,
VSU0810572, VSU0810574, VSU0810575, VSU0810576, VSU0810577, VSU0810578, VSU0810579,
VSU0810581, VSU0810582, VSU0810583, VSU0810584, VSU0810585, VSU0810587, VSU0810588,
VSU0810589, VSU0810590, VSU0810591, VSU0810593, VSU0810594, VSU0810595, VSU0810596,
VSU0810597, VSU0810598, VSU0810599, VSU0810600, VSU0810609, VSU0810610, VSU0810611,
VSU0810612, VSU0810613, VSU0810614, VSU0810615, VSU0810616, VSU0810617, VSU0810618,
VSU0810619, VSU0810620, VSU0810621, VSU0810622, VSU0810623, VSU0810624, VSU0810625,
VSU0810626, VSU0810627, VSU0810628, VSU0810629, VSU0810630, VSU0810631, VSU0810632,
VSU0810633, VSU0810634, VSU0810635, VSU0810636, VSU0810637, VSU0810638, VSU0810639,
VSU0810640, VSU0810641, VSU0810642, VSU0810643, VSU0810644, VSU0810645, VSU0810646,
VSU0810648, VSU0810659, VSU0810660, VSU0810661, VSU0810662, VSU0810663, VSU0810664,
VSU0810665, VSU0810666, VSU0810668, VSU0810669, VSU0810670, VSU0810671, VSU0810672,
VSU0810674, VSU0810675, VSU0810676, VSU0810677, VSU0810678, VSU0810679, VSU0810680,
VSU0810681, VSU0810682, VSU0810683, VSU0810685, VSU0810686, VSU0810687, VSU0810688,
VSU0810689, VSU0810690, VSU0810691, VSU0810692, VSU0810694, VSU0810695, VSU0810696,
VSU0810697, VSU0810698, VSU0810699, VSU0810700, VSU0810701, VSU0810702, VSU0810703,
VSU0810704, VSU0810705, VSU0810706, VSU0810707, VSU0810708, VSU0810709, VSU0810710,
VSU0810711, VSU0810712, VSU0810713, VSU0810714, VSU0810715, VSU0810716, VSU0810718,
VSU0810719, VSU0810720, VSU0810721, VSU0810722, VSU0810723, VSU0810724, VSU0810726,
VSU0810727, VSU0810728, VSU0810729, VSU0810730, VSU0810731, VSU0810732, VSU0810733,
VSU0810734, VSU0810735, VSU0810736, VSU0810737, VSU0810738, VSU0810740, VSU0810741,
VSU0810742, VSU0810743, VSU0810744, VSU0810745, VSU0810746, VSU0810747, VSU0810748,
VSU0810749, VSU0810750, VSU0810751, VSU0810752, VSU0810753, VSU0810754, VSU0810755,
VSU0810756, VSU0810757, VSU0810758, VSU0810759, VSU0810760, VSU0810761, VSU0810762,
VSU0810763, VSU0810764, VSU0810765, VSU0810766, VSU0810767, VSU0811516, VSU0811517,
VSU0811518, VSU0811519, VSU0811521, VSU0811522, VSU0811523, VSU0811525, VSU0811526,

VSU0811527, VSU0811528, VSU0811529, VSU0811530, VSU0811531, VSU0811532, VSU0811533,
VSU0811534, VSU0811535, VSU0811536, VSU0811537, VSU0811538, VSU0811539, VSU0811540,
VSU0811541, VSU0811542, VSU0811543, VSU0811544, VSU0811545, VSU0811546, VSU0811547,
VSU0811548, VSU0811549, VSU0811550, VSU0811551, VSU0811552, VSU0811553, VSU0811554,
VSU0811555, VSU0811556, VSU0811557, VSU0811558, VSU0811559, VSU0811560, VSU0811561,
VSU0811562, VSU0811563, VSU0811564, VSU0811565, VSU0811566, VSU0811567, VSU0811568,
VSU0811569, VSU0811570, VSU0811571, VSU0811572, VSU0811573, VSU0811574, VSU0811575,
VSU0811576, VSU0811577, VSU0811578, VSU0811579, VSU0811580, VSU0811582, VSU0811583,
VSU0811584, VSU0811585, VSU0811586, VSU0811587, VSU0811588, VSU0811589, VSU0811590,
VSU0811591, VSU0811592, VSU0811593, VSU0811594, VSU0811595, VSU0811597, VSU0811598,
VSU0811599, VSU0811600, VSU0811601, VSU0811602, VSU0811603, VSU0811605, VSU0811606,
VSU0811608, VSU0811610, VSU0811611, VSU0811612, VSU0811613, VSU0811628, VSU0811629
出荷数量 ：９７２台（＊）
出荷時期：平成１８年３月３１日～平成２０年１２月２５日
3. 製造販売業者等名称
製造販売業者の名称
製造販売業者の所在地
許可の種類
許可番号
輸入先製造業者：フクダ電子株式会社：東京都文京区本郷三丁目３９番４号：第一種医療機器製造販売業：１３Ｂ１Ｘ００００３：セイム社（フランス）、レスメド社（オーストラリア）

4. 回収理由
機器の製造工程の組み立て誤差により、換気流量を調節するプロポーショナルバルブの動作が不安定となりアラームが発生する事例が発生しました。不良発生は極めて稀ですが可能性を完全に否定できない為、患者様の安全を第一に考え自主回収致します。

5. 危惧される具体的な健康被害
医薬発第 248 号 2001 年 3 月 27 日「生命維持装置である人工呼吸器に関する医療事故防止策について」に従い、(1)人工呼吸器を使用する際には、「警報機能付きパルスオキシメータ」又は「警報機能付きカプノメータ」を併用し、常に患者の状態を監視する旨、(2)人工呼吸器を使用する際には、非常の事態を想定し、何らかの原因により人工呼吸器が機能しなくなった場合に備え、代替の換気装置や手動式人工呼吸器をいつでも使用出来る体制を整える旨を添付文書及び取扱い説明書に明記し周知しております。また、在宅で使用する場合においても医療機関の管理監督の下、緊急時に対応出来る体制が整えられております。よってプロポーショナルバル
ブが不安定となった場合換気動作が停止することがありますが、アラームが発生し異常を知らせるため、適切に対処が出来、重篤な健康被害は回避出来ると考えております。なお、現在までに本不具合による健康被害の報告は受けておりません。

6. 回収開始年月日
平成２１年３月１２日（情報提供開始日）

7. 効能, 効果又は用途等(1)在宅用人工呼吸器 クリーンエア ＶＳ ＳＥＲＥＮＡ
本装置は、在宅及び医療機関において、安定した状態にある人工呼吸療養者が持続的に２段階の圧力（別々に設定した吸気圧及び呼気圧）で換気を行う非侵襲式人工呼吸器として使用する。さらにパラメータの設定により経鼻的持続陽圧呼吸療法にも使用する。
(2) 人工呼吸器

クリーンエア ＶＳ

ＩＮＴＥＧＲＡ

本装置は、在宅及び医療機関において、空気及び酸素と空気の混合ガスを機械的調節のもとで、マスクもしくは気管切開による気管内チューブを介して換気を行う人工呼吸器として使用する。
(3) 人工呼吸器 クリーンエア ＶＳ ＵＬＴＲＡ
本装置は、在宅及び医療機関において、空気及び酸素と空気の混合ガスを機械的調節のもとで、マスクもしくは気管切開による気管内チューブを介して換気を行う人工呼吸器として使用する。

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、納入先へ情報を提供するとともに回収を実施致します。

9. 担当者名及び連絡先
連住絡

先：フクダ電子株式会社
所：東京都文京区本郷三丁目３９番４号
電話 ０３（５６８４）１６９４
FAX
０３（５６８４）１３９８
担当者氏名：田北 徳生、 二俣 宗聖