医療機器自主回収のお知らせ(クラスI)|厚生労働省
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医療機器自主回収のお知らせ(クラスI)|厚生労働省
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This page announces the voluntary recall of implantable cardioverter-defibrillators manufactured by St. Jude Medical by the Japanese Ministry of Health, Labour and Welfare. The recalled products include multiple models of Ellipse Limited, Ellipse, Neutrino ICD Limited, and Neutrino ICD devices. Although no serious health incidents have been reported to date, the company initiated this precautionary recall. Patient monitoring of already-implanted devices is included in the recall process.
