China NMPA Product Recall - Specific electromagnetic wave therapy device

Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary Class III recall on October 22, 2020, concerning certain batches of its CO-10 electromagnetic wave treatment products. These products, specifically one batch comprising ten units manufactured in May 2018, were found to be non-compliant with section 42.5 of the YY0306-2008 standard. The primary issue identified was a design flaw where a critical component, which is mandated to require tools for removal, could be detached without the use of tools. This deviation from the established technical standard was formally reported to the National Medical Products Administration (NMPA), China's key regulatory body for medical devices. The company's required action involved executing a voluntary recall of all affected product batches. A detailed Medical Device Recall Event Report Form, dated January 18, 2019, documented the scope and reasons for this recall, reinforcing the company's commitment to address the product's non-conformance and ensure it meets safety and quality criteria for its intended use in adjunctive treatments.