China NMPA Product Recall - Multi-parameter monitor

Shenzhen Bangjian Biomedical Equipment Co., Ltd. initiated a voluntary Level III recall of its multi-parameter patient monitors, specifically the iM15 model, on December 6, 2018. This action, reported to the National Medical Products Administration (NMPA) in China, affects 27 batches and 317 units registered under Guangdong Medical Device Registration Certificate 20172211184. The company's internal inspection revealed that the alarm function's "selection (configuration) of pause or suppression function" on the iM15 monitors did not meet standard requirements, leading to the recall to ensure regulatory compliance. At the time of the recall, no related adverse events had been reported.

To address the issue, Shenzhen Bangjian Biomedical Equipment Co., Ltd. committed to implementing corrective actions for the product to align with standard requirements. Furthermore, the company will promptly contact customers, issue advisory notices, and provide essential software upgrade packages, detailed upgrade instructions, and revised instruction manual pages. These comprehensive measures are designed to ensure that all affected products, including those already sold, are brought into full compliance with applicable standards.