一般名及び販売名

一般的名称：　遠隔操作式Ｘ線透視撮影台
販売名：
(1) カセッテレスＸ線透視撮影装置　ＴＵシリーズ
(2) カセッテレスＸ線透視撮影台　ＴＵ-６０００
(3) カセッテレスＸ線透視撮影台　ＴＵ-８０００

対象製造番号、数量及び出荷時期

対象製造番号：
(1) ＴＵシリーズ
        KC10134001, KC10134002, KC10134003, KC10135001, KC10135002,
        KC10135003, KC10137001, KC10137002, KC10137003, KC10215301,
        KC10215302, KC10216301, KC10409001, KC10409002, KC10410001,
        KC10410002, KC10410003, KC10413001, KC10413002, KC10432301,
        KC10432302, KC10434301, KC10533301, KC10533302, KC10534301,
        KC10534302, KC10535301, KC10641001, KC10641002, KC10642001,
        KC10642002, KC10771001, KC10771002, KC10918001, KC10918002,
        KC10919001, KC10919002, KC10920001, KC10920002, KC10923001,
        KC10923002, KC10924001, KC10924002, KC11004301, KC11004302,
        KC11004303, KC11004304, KC11112301, KC11112302, KC11119301,
        KC11119302, KC11121301, KC11121302, KC11121303, KC11121304,
        KC11149001, KC11149002, KC11150001, KC11150002, KC11162001,
        KC11162002, KC11243302, KC11245301, KC11245302, KC11275001,
        KC11275002, KC11276001, KC11276002, KC11277001, KC11277002,
        KC11303001, KC11303002, KC11443001, KC11443002, KC11693001,
        KC11693002, KC11726001, KC11726002, KC11727002, KC11971101,
        KC11971102, KC11972101, KC11972102, KC11973101, KC11973102,
        KC11974001, KC11974101, KC11978001, KC11978002, KC11979101,
        KC11979102, KC12146301, KC12146302, KC12152101, KC12152102,
        KC12153101, KC12153102, KC12155101, KC12155102, KC12191301,
        KC12191302, KC12193401, KC12193402, KC12194401, KC12194402,
        KC12458401, KC12458402, KC12459401, KC12459402, KC12552101,
        KC12552102, KC12553102, KC12554101, KC12554102, KC12555101,
        KC12555102, KC12558101, KC12558102, KC12559101, KC12559102,
        KC12621401, KC12621402, KC12621403, KC12621404, KC12622402,
        KC12622403, KC12622404, KC12623402, KC12755402, KC12792101,
        KC12792102, KC12793101, KC12793102, KC12794101, KC12794102,
        KC12795102, KC12799101, KC12799102, KC12942401, KC13003101,
        KC13003102, KC13004101, KC13004102, KC13005101, KC13005102,
        KC13006101, KC13011101, KC13011102, KC13013101, KC13013102,
        KC13213402, KC13244101, KC13244201, KC13249101, KC13249102,
        KC13250101, KC13250102, KC13254102, KC13255101, KC13255102,
        KC13256101, KC13256102, KC13257101, KC13257102, KC13258101,
        KC13258102, KC13259101, KC13261101, KC13261102, KC13262101,
        KC13262102, KC13266401, KC13522101, KC13522102, KC13523101,
        KC13524101, KC13524102, KC13527201, KC13527202, KC13573101,
        KC13756101, KC13911801, KC13911802, KC13911803, KC13912801,
        KC13912802, KC13912803, KC13913801, KC13913802, KC13913803,
        KC13914801, KC13914802, KC13915801, KC13915802, KC13915803,
        KC13916801, KC13916802, KC13917901, KC13917902, KC13917903,
        KC13918901, KC13918902, KC13918903, KC13922902, KC14002101,
        KC14002102, KC14003101, KC14003102, KC14004101, KC14004102,
        KC14007101, KC14007102, KC14030101, KC14030102, KC14158801,
        KC14158802, KC14158803, KC14158803, KC14276101, KC14276102,
        KC14432101, KC14432102, KC14433101, KC14433102, KC14508101,
        KC14605801, KC14605802, KC14605803, KC14606801, KC14606802,
        KC14606803, KC14647101, KC14647102, KC14649101, KC14745101,
        KC14745102, KC14918801, KC14918802, KC14918803, KC14919901,
        KC14919902, KC14959201, KC14959202, KC14961101, KC14961102,
        KC14971101, KC14971102, KC14980201, KC14980202, KC15143802,
        KC15143802, KC15143903, KC15143904, KC15216203, KC15219201,
        KC15221201, KC15221202, KC15222201, KC15222202, KC15223202,
        KC15269201, KC15269202, KC15285201, KC15286201, KC15289201,
        KC15289202, KC15290201, KC15290202, KC15291202, KC15531202,
        KC15533201, KC15533202, KC15600201, KC15600202, KC15607902,
        KC15607903, KC15608901, KC15608902, KC15608903, KC15615901,
        KC15615902, KC15615903, KC15616901, KC15616902, KC15616903,
        KC15757901, KC15757902, KC15757903, KC15771901, KC15771902,
        KC15771903, KC15776901, KC15776902, KC15776903, KC15826202,
        KC15861201, KC15879201, KC15881201, KC15881202, KC15908201,
        KC15908202, KC15912201, KC16043901, KC16043901, KC16044901,
        KC16044902, KC16088201, KC16088202, KC16089201, KC16089202,
        KC16092202, KC16093201, KC16093202, KC16172201, KC16172202,
        KC16265901, KC16265902, KC16265903, KC16266901, KC16266902,
        KC16266903, KC16276901, KC16276902, KC16276903, KC16280901,
        KC16280902, KC16349201, KC16446201, KC16450201, KC16450202,
        KC16539901, KC16539902, KC16539903, KC16540901, KC16540902,
        KC16540903, KC16540903, KC16714201, KC16722201, KC16722202,
        KC16723201, KC16725201, KC16725202, KC16797901, KC16797902,
        KC16797903, KC16798901, KC16798902, KC16798903, KC16804901,
        KC16804902, KC16805901, KC16805902, KC16932201, KC16934201,
        KC16934202, KC16935201, KC16935202, KC17005202, KC17005210,
        KC17006201, KC17066901, KC17066902, KC17067901, KC17067902,
        KC17070901, KC17070902, KC17070903, KC17079201, KC17088201,
        KC17094901, KC17094902, KC17094903, KC17107201, KC17107202,
        KC17108201, KC17216201, KC17216202, KC17217201, KC17220201,
        KC17220202, KC17221201, KC17301201, KC17303201, KC17321201,
        KC17570201, KC17570202, KC17572201, KC17572202, KC17751901,
        KC17751902, KC17818201, KC17818202, KC17818203, KC17835202,
        KC17994301, KC17994302, KC17995201, KC18040901, KC18040902,
        KC18065002, KC18065901, KC18071901, KC18071902, KC18071903,
        KC18073901, KC18073902, KC18073903, KC18146302, KC18146304,
        KC18147301, KC18147302, KC18311901, KC18311902, KC18312901,
        KC18312902, KC18312903, KC18317901, KC18334901, KC18334902,
        KC18466901, KC18466902, KC18466903, KC18468901, KC18468902,
        KC18468903, KC18498001, KC18498002, KC18499001, KC18499002,
        KC18499003, KC18500001, KC18500002, KC18500003, KC18501001,
        KC18501002, KC18507302, KC18509301, KC18509302, KC18509303,
        KC18510301, KC18510302, KC18510303, KC18674301, KC18674302,
        KC18799001, KC18799002, KC18799003, KC18801001, KC18801003,
        KC18803001, KC18803002, KC18807301, KC18807302, KC18807303,
        KC18808301, KC18808302, KC18945301, KC18945302, KC18945304,
        KC18952301, KC18952302, KC19086001, KC19086002, KC19093001,
        KC19093002, KC19093303, KC19094001, KC19094002, KC19094003,
        KC19095001, KC19095002, KC19095003, KC19100002, KC19100003,
        KC19104001, KC19104002, KC19104003, KC19118301, KC19118302,
        KC19279301, KC19279302, KC19279303, KC19279304, KC19398001,
        KC19398002, KC19403001, KC19403002, KC19403003, KC19404001,
        KC19404002, KC19404003, KC19407001, KC19407002, KC19407003,
        KC19408001, KC19408002, KC19411001, KC19411002, KC19411003,
        KC19413301, KC19546801, KC19546802, KC19546803, KC19547801,
        KC19547802, KC19547803, KC19548801, KC19548802, KC19548803,
        KC19549801, KC19549802, KC19549803, KC19550801, KC19550802,
        KC19550803, KCR0189103, KCR0217103, KCR0228103, KCR0513101,
        KCR0588103, KCR0648103, KCR0661102, KCR0661102, KCR0736103,
        KCR0738103, KCR0752103, KCR0845103, KCR1136103, KCR6451802,
        KCR6533902, KCR6540901, KCR6910902, KCR7183902, KCR7757902,
        KCR7766903, KCR8087903

(2) ＴＵ-６０００
        KC10539301, KC10539302, KC10540301, KC10540302, KC11122301,
        KC11241301, KC11241302, KC11242401, KC11242402, KC12197401,
        KC12197402, KC12306401, KC12947401, KC12947402, KC13215401,
        KC13215402, KC13297402, KC18935301, KC18935302, KC18935303,
        KCR2896203, KCR2943302, KCR3159302

(3) ＴＵ-８０００
        KC10714301, KC11123301, KC11377301, KC12344401, KC12344402,
        KC12460401, KC12460402, KC12461401, KC12461402, KC12624401,
        KC12624402, KC13044401, KC13044402, KC13298401, KC18549315,
        KC18936302, KCR2893303, KCR2933803

出荷数量　：　５７８台
出荷時期　：　平成１０年７月２５日〜平成１６年８月６日

製造業者等名称

会社の名称　：　株式会社　日立メディコ
本社所在地　：　東京都千代田区内神田一丁目１番１４号（日立鎌倉橋別館）
薬事の業態　：　医療用具の製造業
製造所の名称　 ：　株式会社　日立メディコ 柏事業所
製造所の所在地 ：　千葉県柏市新十余二２番地１
業許可番号　：　１２ＢＺ００５８

回収〈改修〉理由

透視撮影台操作時、圧迫筒が圧迫待機状態で天板起倒操作をしたまま、透視台を
被検者乗降位置へ移動させるためのリターン釦を押すと、天板昇降動作が自動制御
状態を外れて下降動作を継続し、天板支持枠が床に接触することが稀に発生する
ため、当該のソフトウェアを変更する改修を実施させて頂くことにしました。

危惧される具体的な健康被害

この不具合が発生した場合、透視撮影台の天板を支持する枠が床に接触する可能
性があります。この時、天板に乗っている被検者は揺れを感じますが、転倒等による
健康被害発生の可能性は、まず考えられません。
なお、これまでに健康被害の報告は受けておりません。

回収（改修）開始年月日

平成１６年９月１７日

効能・効果又は用途等

本装置は、Ｘ線を発生させて撮影を行い、フィルム等に人体透過後の画像を投影させ、
検査、診断に利用する装置で、医師又は診療放射線技師等の有資格者が使用します。

その他

対象医療機関の名称と所在地は全て把握しております。

担当者名及び連絡先

担当者名　：　品質保証本部　　　平出　博一　、　河辺　信克

連絡先　：　株式会社　日立メディコ
　　　　千葉県柏市新十余二２番地１
　　　　電　話　　０４−７１３１−４１６７
　　　　ＦＡＸ　　０４−７１３１−４７７４