FDA Alerting About Potential Need For Early Device Replacement Of Boston Scientific Accolade Pacemaker Devices; Boston Scientific Announced Recall For Subset Of Accolade Pacemaker Devices With Increased Risk To Permanently Enter Safety Mode
FDA Alerting About Potential Need For Early Device Replacement Of Boston Scientific Accolade Pacemaker Devices; Boston Scientific Announced Recall For Subset Of Accolade Pacemaker Devices With Increased Risk To Permanently Enter Safety Mode
FDA警告可能需要提前更換波士頓科學Accolade心臟起搏器；波士頓科學已宣佈召回部分存在進入安全模式風險增加的Accolade心臟起搏器。
Date Issued: December 16, 2024
發佈日期：2024年12月16日
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about the potential need for early device replacement of Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers.
美國食品藥品監督管理局（FDA）正在提醒患者、護理人員和醫療保健提供者注意波士頓科學公司（Boston Scientific）Accolade心臟起搏器設備可能需要提前更換，這些設備包括Accolade、Proponent、Essentio和Altrua 2標準型（SL）及延長型（EL）起搏器，以及Visionist和Valitude心臟再同步治療起搏器。
Boston Scientific announced a recall for a subset of Accolade pacemaker devices with an increased risk to permanently enter Safety Mode, which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart...
波士頓科學公司宣佈召回一部分Accolade心臟起搏器設備，這些設備有較高風險...
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