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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