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平成25年11月19日作成
一般名及び販売名
一般的名称： Ｘ線平面検出器出力読取式デジタルラジオグラフ 販売名 ： ディジタルラジオグラフィー装置 ＤＡＲ‐８０００ｆ
対象ロット、数量及び出荷時期
製造番号： 0161G65102,0161G65104,0161G65105,0161G65202,0161G65203,0161G65204,0161G65205,0161G65301 0161G65302,0161G65305,0161G65401,0161G65402,0161G65501,0161G65503,0161G65504,0161G65505 0161G65601,0161G65602,0161G65604,0161G65605,0161G65701,0161G65702,0161G65704,0161G65705 0161G65801,0161G65802,0161G65803,0161G65805,0161G65902,0161G65903,0161G66001,0161G66002 0161G66003,0161G66005,0161G66101,0161G66102,0161G66103,0161G66104,0161G66105,0161G66201 0161G66202,0161G66203,0161G66204,0161G66205,0161G66301,0161G66303,0161G66304,0161G66401 0161G66402,0161G66404,0161G66405,0161G66501,0161G66502,0161G66503,0161G66602,0161G66603 0161G66605,0161G66701,0161G66702,0161G66705,0161G66801,0161G66902,0161G66903,0161G67002 0161G67003,0161G67005,0161G67101,0161G67103,0161G67105,0161G67203,0161G67204,0161G67205 0161G67301,0161G67401,0161G67402,0161G67403,0161G67404,0161G67405,0161G67601,0161G67602 0161G67603,0161G67604,0161G67605,0161G67701,0161G67704,0161G67803,0161G67805,0161G68102 0161G68103,0161G68104,0161G68301,0161G68302,0161G68303,0161G68304,0161G68305,0161G68401 0161G68402,0161G68403,0161G68404,0161G68405,0161G68501,0161G68502,0161G68503,0161G68504 0161G68505,0161G68601,0161G68602,0161G68603,0161G68604,0161G68801,0161G69001,0161G69002 0161G69004,0161G69005,0161G69102,0161G69103,0161G69105,0161G69301,0161G69302,0161G69303 0161G69304,0161G69401,0161G69402,0161G69405,0161G69501,0161G69602,0161G69604,0161G69605 0161G69704,0161G69902,0161G69903,0161G70001,0261G65101,0261G65202,0261G65204,0261G65302 0261G65304,0261G65401,0261G65403,0261G65501,0261G65502,0261G65602,0261G65604,0261G65701 0261G65703,0261G65901,0261G66002,0261G66003,0261G66004,0261G66101,0261G66102,0261G66103 0261G66104,0261G66201,0261G66203,0261G66204,0261G66301,0261G66304,0261G66401,0261G66402 0261G66403,0261G66404,0261G66601,0261G66704,0261G66804,0261G66901,0261G66903,0261G67002 0261G67003,0261G67004,0261G67101,0261G67104,0261G67303,0261G67304,0261G67504,0261G67601 0261G67602,0261G67603,0261G67604,0261G67803,0261G67904,0261G68001,0261G68102,0261G68201 0261G68202,0261G68302,0261G68303,0261G68401,0261G68402,0261G68403,0261G68404,0261G68501 0261G68502,0261G68503,0261G68504,0261G68602,0261G68603,0261G68604,0261G68701,0261G68702 0261G68703,0261G68801,0261G68802,0261G68803,0261G68804,0261G68902,0261G69003,0261G69201 0261G69301,0261G69302,0261G69303,0261G69304,0261G69401,0261G69404,0261G69501,0261G69502 0261G69503,0261G69504,0261G69601,0261G69603,0261G69604,0261G69701,0261G69702,0261G69703 0261G69802,0261G69803,0261G69804,0261G69901,0261G70001,0261G70003,0261G70004,0361G65201 0361G65203,0361G65302,0361G65303,0361G65304,0361G65401,0361G66001,0361G66002,0361G66003 0361G66004,0361G66101,0361G66102,0361G66103,0361G66104,0361G66202,0361G66203,0361G66302 0361G66501,0361G66502,0361G66503,0361G66504,0361G66601,0361G66602,0361G66603,0361G66604 0361G66801,0361G66802 3M72BF10A001,3M72BF10B001,3M72BF10B002,3M72BF10B003,3M72BF10B004,3M72BF10C001,3M72BF10C002 3M72BF111001,3M72BF111003,3M72BF111004,3M72BF112002,3M72BF112003,3M72BF112004,3M72BF113001 3M72BF113002,3M72BF113003,3M72BF113004,3M72BF113005,3M72BF113006,3M72BF113007,3M72BF113008 3M72BF114001,3M72BF114003,3M72BF116001,3M72BF117001,3M72BF119001,3M72BF119002,3M72BF119003 3M72BF119004,3M72BF119005,3M72BF119006,3M72BF119007,3M72BF11A001,3M72BF11A002,3M72BF11A003 3M72BF11A004,3M72BF11A005,3M72BF11B001,3M72BF11C001,3M72BF11C002,3M72BF11C003,3M72BF11C004 3M72BF11C005,3M72BF11C006,3M72BF11C007,3M72BF11C008,3M72BF121001,3M72BF121002,3M72BF121003 3M72BF121004,3M72BF121005,3M72BF122001,3M72BF122002,3M72BF122003,3M72BF123001,3M72BF123002 3M72BF123004,3M72BF123005,3M72BF124001,3M72BF124002,3M72BF124003,3M72BF124004,3M72BF124005 3M72BF124006,3M72BF125001,3M72BF125002,3M72BF125003,3M72BF126001,3M72BF126002,3M72BF126003 3M72BF126004,3M72BF126005,3M72BF127001,3M72BF127002,3M72BF128001,3M72BF128002,3M72BF128003 3M72BF129001,3M72BF129002,3M72BF129003,3M72BF129004,3M72BF129005,3M72BF129006,3M72BF12A001 3M72BF12B001,3M72BF12B002,3M72BF12B003,3M72BF12C001,3M72BF12C002,3M72BF12C003,3M72BF12C004 3M72BF131001,3M72BF131002,3M72BF132001,3M72BF132002,3M72BF132003,3M72BF132004,3M72BF132005 3M72BF133001,3M72BF133002,3M72BF133003,3M72BF133004,3M72BF133005,3M72BF134001,3M72BF20B001 3M72BF20C001,3M72BF212001,3M72BF213001,3M72BF214001,3M72BF214002,3M72BF215001,3M72BF216001 3M72BF217001,3M72BF217002,3M72BF218001,3M72BF218002,3M72BF219001,3M72BF219002,3M72BF219003 3M72BF21C001,3M72BF21C002,3M72BF21C003,3M72BF221001,3M72BF222001,3M72BF222002,3M72BF222003 3M72BF223001,3M72BF223002,3M72BF224001,3M72BF224002,3M72BF226001,3M72BF227001,3M72BF228001 3M72BF228002,3M72BF228003,3M72BF229001,3M72BF229002,3M72BF22A001,3M72BF22B001,3M72BF22B002 3M72BF22B003,3M72BF22C001,3M72BF22C002,3M72BF232001,3M72BF232002,3M72BF233001,3M72BF233002 3M72BF234001,3M72C4517001,3M72C4A17001,3M72C4A22001,3M72C4A27001,3M72C4A29001 数量： 411台 出荷時期：平成18年4月〜平成25年4月
製造販売業者等名称
名称 ： 株式会社島津製作所 所在地 ： 京都府京都市中京区西ノ京桑原町１番地 許可の種類： 第一種医療機器製造販売業 許可番号 ： 26B1X00003
改修理由
当該装置において、撮影終了直後に特定のタイミングでX線照射の操作を行った場合に、直前に撮影した画像が正 しく保存されない可能性があることが判明しました。 そのため、改善されたソフトウェアへの変更を自主改修として実施致します。
危惧される具体的な健康被害
画像が正しく保存されなかった場合には、再度撮影を行う可能性があります。その場合、線量は通常のＸ線検査 で照射されるレベルであり、重篤な健康被害が発生する可能性は無いと考えております。 なお、本事象により健康被害に係る報告は受けておりません。
改修開始年月日
平成25年11月18日
効能・効果又は用途等
人体を透過したＸ線を平面検出器で撮像し、コンピュータ処理した画像情報を診断のために提供する装置で、医 師あるいは診療放射線技師等の有資格者が使用します。
その他
対象となる装置の納入先は全て特定しており、納入先には連絡の上、改修作業を実施いたします。
担当者及び連絡先
担当者 ： 谷川 勝哉、高松 等 連絡先 ： 株式会社島津製作所 電話番号： 075-823-1928 FAX番号 ： 075-823-1377