openFDA 器械召回·· 8 天前精选AI 评分42
Automated Impella Controller 因净化盒识别问题被召回
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
AI 导读
openFDA 器械召回信息显示，Automated Impella Controller（AIC）因净化压力传感器组件的净化标志部件故障，存在净化盒识别问题的潜在风险而被召回。
推荐理由
召回涉及多国版本的Impella控制器，核心原因是净化压力传感器组件故障，可了解该器械的识别风险范围。
来源：openFDA 器械召回 · api.fda.gov