China NMPA Product Recall - High voltage potential therapy device

Suzhou Jiujiu Shou Medical Device Co., Ltd. initiated a voluntary Class III recall of its high voltage potential therapy device, identified by Registration Certificate Code 国械注准 and Product Number JJS-A9A18001. This recall was prompted by findings from a 2018 national medical device spot check conducted by the National Medical Products Administration (NMPA). The primary violation identified was non-compliance with regulations concerning the "marking of controllers and instruments" on the device. While a specific inspection date isn't explicitly stated, an inspection report from March 13, 2018, is referenced, indicating the period of non-compliance discovery. The company formally received a "Brief Description of Corrective Action for National Medical Device Spot Check Product" in September 2018, outlining the necessary steps, including recall requirements. Suzhou Jiujiu Shou Medical Device Co., Ltd. confirmed and completed these corrective actions in adherence to regulatory requirements and internal company procedures, addressing the identified labeling issue. This voluntary recall underscores the regulatory framework's emphasis on accurate medical device identification and labeling for patient safety.