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 a press release from Japan's Ministry of Health, Labour and Welfare regarding the voluntary recall of medical devices. Japan Microsystems CRM Co., Ltd. has initiated a recall and patient monitoring program for 375 units of "XFine Lead," an endocardial pacemaker lead. The recalled devices were shipped between October 2019 and June 2022 and are classified as Class I recalls. Contact information for inquiries is provided through the Surveillance and Guidance Division and the Drug Safety Division of the Pharmaceutical and Medical Device Safety Bureau.
