自主回収｜クラス１｜報道発表資料｜厚生労働省
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自主回収｜クラス１｜報道発表資料｜厚生労働省
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This page is an official notice released by Japan's Ministry of Health, Labour and Welfare on November 28, 2018, regarding the voluntary recall of medical devices. Boston Scientific Japan announced the recall of three products: implantable cardiac pacemakers "Accolade" and "Accolade MRI," and an implantable biventricular pacing pulse generator without defibrillation function "Valitude." This is classified as a Class I recall. The total number of units distributed was 24,950, shipped between November 2015 and November 2030.
