openFDA 器械召回·· 8 天前AI 评分32
Impella Optical Controller 因 purge cassette 识别问题被召回（涉及 AU/EU/IN/UK/US 版本）
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
AI 导读
Impella Optical Controller 因 purge pressure sensor assembly 的 purge flag 组件失效，可能导致 purge cassette 识别问题而被召回，涉及产品代码 0042-0010-AU、0042-0010-EU、0042-0010-IN、0042-0010-UK 和 0042-0010-US。
来源：openFDA 器械召回 · api.fda.gov