精选安全与合规美国 FDAT1084
Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers
🤖 AI 摘要
A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
分析模型:rule-based-v3 · 07-09 06:59
评分详情
综合分 84/100
信源权威
95
影响范围
75
时效性
50
合规紧急
90
行业关注
90
MedWatch Safety Alerts (医疗产品安全警报)
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