China NMPA Product Recall - Fetal/Maternal Monitor

Shenzhen Mindray Medical International Co., Ltd. initiated a voluntary Class III recall of certain fetal/maternal monitors, as announced by the National Medical Products Administration (NMPA) on August 2, 2021. The recall stems from a labeling deficiency where the main unit of some monitors, specifically those under Guangdong Medical Device Registration Certificate No. 20202180953, lacked the required waterproof rating markings. This issue was reported by Shenzhen Mindray Medical International Co., Ltd. itself, demonstrating the company's proactive compliance with regulatory standards. The recall is managed under the regulatory framework of the NMPA, with details on affected product models, specifications, and batches provided in the 'Medical Device Recall Event Report Form.' This action underscores the importance of accurate product labeling for medical devices to ensure user safety and compliance with national regulations.