China NMPA Product Recall - Multi-parameter patient monitor (WPM-80)

Shenzhen Huasheng Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its multi-parameter patient monitor, model WPM-80. This action follows a random inspection that identified the device as non-compliant with established standards. The recall specifically targets products covered under Registration Certificate No. "粤械注准20172211167".

Published on March 22, 2022, by the National Medical Products Administration (NMPA) and sourced from the Guangdong Provincial Drug Administration website, this announcement underscores the company's commitment to product safety and quality assurance. While specific inspection dates are not detailed, the recall decision stems directly from findings of this regulatory oversight. The company is taking proactive steps to address the identified issues, ensuring patient safety is prioritized.

Detailed information regarding affected batches and specific product details are referenced in the accompanying "Medical Device Recall Event Report Form". This voluntary recall demonstrates the manufacturer's adherence to regulatory expectations and responsibility in managing product non-conformities, aligning with the regulatory framework governing medical devices in China.