China NMPA Product Recall - Multi-parameter monitor

Shenzhen Huasheng Medical Technology Co., Ltd. initiated a voluntary Class III recall of its multi-parameter patient monitor (product serial number PM12-0702682) on March 18, 2022. This action followed a random inspection by regulatory authorities, which identified that the device failed to meet established product standards. The recall impacts a specific batch of monitors, identified by Registration Certificate No.: 20142070168. The regulatory oversight for this recall falls under the purview of the National Medical Products Administration (NMPA) and the Guangdong Provincial Drug Administration in China. A Level III recall signifies that the use of or exposure to a violative product is not likely to cause adverse health consequences. Shenzhen Huasheng Medical Technology Co., Ltd. is responsible for implementing this recall, with further detailed information, including specific models, specifications, and batch numbers, provided in the attached "Medical Device Recall Event Report Form." The company's proactive measure aims to address the identified non-compliance and ensure product safety.