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令和 5年10月30日作成
一般的名称及び販売名
一般的名称： 汎用超音波画像診断装置 販売名 ： デジタル超音波診断装置 Ｎｏｂｌｕｓ
対象ロット、数量及び出荷時期
(1)デジタル超音波診断装置 Ｎｏｂｌｕｓ 20476095 20476096 204E8237 204E8238 204E8239 204E8240 204E8241 204E8242 204E8243 204E8244 204E8245 204E8246 204E8247 204E8249 204E8250 204E8251 204E8252 204E8253 204E8254 204E8255 204E8256 204E8257 204E8258 204E8259 204E8260 204E8261 204E8262 204E8263 204E8264 204E8265 204E8266 204E8267 204E8268 204E8269 204E8270 204E8271 204E8272 204E8273 204E8274 204E8275 204E8276 204E8283 204E8284 204E8285 204E8286 204E8287 204E8288 204E8289 204E8290 204E8291 204E8292 204E8293 204E8294 204E8295 204E8296 204E8297 204E8298 204E8300 204E8301 204E8322 204E8323 204E8324 204E8325 204E8326 204E8327 204E8328 204E8329 204E8330 204E8331 204E8337 204E8338 204E8339 204E8340 204E8341 204E8342 204E8343 204E8344 204E8345 204E8346 204E8347 204E8348 204E8349 204E8350 204E8351 204E8352 204E8353 204E8354 204E8355 204E8356 204E8357 204E8358 204E8359 204E8360 204E8361 204E8362 204E8363 204E8364 204E8366 204E8367 204E8368 204E8369 204E8370 204E8371 204E8372 204E8373 204E8374 204E8375 204E8376 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製造販売業者等名称
製造販売業者の名称 ： 富士フイルムヘルスケア株式会社 製造販売業者の所在地： 千葉県柏市新十余二2番地１ 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 12B1X10023
改修理由
当該装置において、ACアダプタと電源ケーブルの頻繁な抜差し等を続けた場合に、機械的な耐久性の問題より、 ACアダプタ内でコネクタの接触不良個所に発熱が生じ、周囲の可燃物へ発火する事象が確認されたため、改良し たＡＣアダプタへ交換する自主改修を実施します。
危惧される具体的な健康被害
ACアダプタ内でコネクタの接触不良個所に発熱が生じ周囲の可燃物へ発火する事象が発生しましたが、装置は医 療従事者により常に監視されており、異常が発生した場合においても直ちに適切な処置を取れる事から、医療従 事者、患者様に重篤な健康被害が発生する事は無いと考えております。なお、国内において本事象による健康被 害の発生は、報告されておりません。
改修開始年月日
令和5年10月30日 （情報提供の開始）
効能・効果又は用途等
超音波を用いて体内の形状、性状または動態を可視化し、画像情報を診断のために提供する。
その他
納入先医療機関は全て特定しておりますので、自主改修する旨を文書で通知し改修します。
担当者及び連絡先
担当者 ： 品証薬事部 薬事・規格グループ 薬事安全管理チーム 岡本泰生 連絡先 ： 富士フイルムヘルスケア株式会社 電話番号： 04-7131-4167 FAX番号 ： 04-7131-4774