China NMPA Product Recall - Fetal/Maternal Monitor

Shenzhen Mindray Medical International Co., Ltd. has initiated a voluntary Class 3 recall for 40 units of its Fetal/Maternal Monitors, specifically models F15 and F15 Air, distributed within China. The recall, reported on July 26, 2021, stems from a recent self-inspection that identified a critical labeling inconsistency: the waterproof rating "IPX2" was missing from the main unit labels. This omission violates the product's registered technical requirements, necessitating corrective action under the National Medical Products Administration (NMPA) regulatory framework. The affected monitors are designed for comprehensive physiological monitoring, including maternal electrocardiogram, heart rate, blood pressure, oxygen saturation, temperature, respiration, uterine contraction, and fetal heart rate and movement. Mindray emphasizes that while the label error is significant for regulatory compliance, it does not impair the monitors' normal function or safety. To rectify the issue, the company is notifying all customers and providing corrected main unit labels for immediate replacement. This swift action ensures adherence to stringent labeling standards and regulatory protocols, demonstrating Mindray's commitment to product integrity and compliance.