China NMPA Product Recall - Corneal endothelial microscopy

Nidec Corporation, through its Beijing Representative Office, initiated a voluntary Class III recall for its manufactured corneal endothelial microscopes (Registration No.: 20172221922). This announcement was made public on February 2, 2019, by the National Medical Products Administration (NMPA). The primary issue identified was that the electromagnetic waves emitted by the product exceeded established electromagnetic compatibility standards. Under the oversight of the NMPA, Nidec Corporation reported this non-compliance, leading to the decision to recall the affected medical devices. A Class III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The regulatory framework requires companies to take corrective actions when products do not meet safety and performance standards. As a result of these findings, Nidec Corporation is undertaking the required action of recalling all affected units of the corneal endothelial microscopes. Detailed information concerning the specific models, specifications, and batches of the products involved in this recall is available in the "Medical Device Recall Event Report Form," which further outlines the scope and procedures for this action. This ensures patient safety and compliance with national medical device regulations.