www.mhlw.go.jp/stf/newpage_00248.html
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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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https://www.mhlw.go.jp/stf/newpage_00248.html
About this page
This page announces a Class I medical device recall issued by the Ministry of Health, Labour and Welfare on July 12, 2018. Japan Lifeline Co., Ltd. initiated a voluntary recall of cardiac pacemaker-related devices: "Platinum ICD" (4 units) and "Platinum CRT-D" (18 units). These devices were shipped between 2016 and 2017. The recall involves dual-chamber implantable cardioverter-defibrillators and biventricular pacing pulse generators. Additional details are available in Tokyo's press release.
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