China NMPA Product Recall - Color Doppler ultrasound system

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Level III recall for several models of its Color Doppler Ultrasound Systems, as announced by the National Medical Products Administration (NMPA) on November 25, 2020. The recall was prompted by the company's discovery that the maximum electromagnetic radiation intensity of certain units within the specified systems might not conform to the product's technical requirements. Specifically, this non-compliance was identified at particular single-frequency points within the high-frequency band. The regulatory oversight for this action falls under the purview of the NMPA, with the announcement originating from the Guangdong Provincial Drug Administration website. The affected devices, identified by Registration Certificate Nos.: 粤械注准20182230139, 粤械注准20182230242, 粤械注准20182230383, and 粤械注准20192061111, are subject to this recall. A Level III recall signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. As part of the required actions, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is responsible for managing the recall process. Comprehensive details regarding the specific product models, specifications, and affected batches are documented in the "Medical Device Recall Event Report Form," which was provided as an attachment. This voluntary recall underscores the company's commitment to product safety and compliance with established technical and regulatory standards under the NMPA framework.