China NMPA Product Recall - Disposable sterile medical laser fiber - Greenlight MoXy Fiber Optic

Polarization International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall on March 31, 2020, for its disposable sterile medical laser fiber, specifically the Greenlight MoXy Fiber Optic. This action was prompted by a requirement from ANSM, the French regulatory body, regarding a planned update to the product's instruction manual (DFU). The core issue is the need to communicate this updated implementation plan effectively to all existing customers. The regulatory framework involves both China's National Medical Products Administration (NMPA), which published the recall, and the French ANSM, which mandated the update. As part of the required actions, Polarization International Medical Trading (Shanghai) Co., Ltd., on behalf of manufacturer Boston Scientific, must issue a Field Safety Notification (FSN) to ensure all affected customers receive the critical information about the instruction manual update. Further details on specific product models and batches are available in the accompanying Medical Device Recall Event Report Form.