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ID:15508
発表
2011/02/09
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改修

超音波画像診断装置 穿刺ガイドライン表示に不具合


Mochida Siemens Medical Systems 「汎用超音波画像診断装置」 改修

事業者:

持田シーメンスメディカルシステム株式会社

連絡先 事業者サイト 事業者情報一覧
製品:

ソノビスタ FX

ジャンル: 医療機器 関連ワード:

回収率: -   (回収数:-/対象数:1,004件)
重要なお知らせ: http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-4269
ご連絡先・お問い合せ(受付担当者に「リコールプラスを見ました」とお伝えください)
持田シーメンスメディカルシステム(株) CS部
担当者:安全管理責任者 山崎文義、品質保証責任者 前田誠
TEL:03-5423-8700
FAX:03-5423-8511
対象
販売名:ソノビスタ FX
製造番号:
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出荷台数:1,004台
出荷時期:2009/01~2010/12
対処方法
改修(ソフトウェア修正)
内容
持田シーメンスメディカルシステム(株)は、「ソノビスタ FX」について、国内納入先で患者使用前の動作確認の水槽テストを行ったところ、穿刺する範囲の目安である穿刺ガイドラインが穿刺針とずれて表示されていることが確認されたため、改修を実施する。ソフトウェアの修正を行う。(R+編集部)
ご連絡先・お問い合せ(受付担当者に「リコールプラスを見ました」とお伝えください)
持田シーメンスメディカルシステム(株) CS部
担当者:安全管理責任者 山崎文義、品質保証責任者 前田誠
TEL:03-5423-8700
FAX:03-5423-8511
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