China NMPA Product Recall - Specific electromagnetic wave therapy device

Chongqing Bozhihan Technology Co., Ltd. initiated a voluntary Class III recall of specific electromagnetic wave therapy devices, as reported to the National Medical Products Administration (NMPA) on July 10, 2018, with the recall notification published on October 22, 2020. The decision to recall was prompted by two primary concerns affecting product performance and user experience. The first issue identified was external damage to the devices during transportation, which potentially altered the product's intended functionality. The second concern involved the thermal response time, which was found to exceed 20 minutes. This delay could inconvenience customers and prolong their waiting period before using the therapeutic device. Operating under the oversight of the NMPA, Chongqing Bozhihan Technology Co., Ltd. took proactive measures to address these product deficiencies. The recall specifically targeted five units from batches 7092346-7092350 (model OH-LJ Vertical Single Head), sold within China. While the detailed corrective actions beyond the voluntary recall (such as scrapping or specific handling methods) were not fully elaborated in the provided document, the company initiated the recall to mitigate potential risks and improve product quality. This action underscores the company's commitment to product safety and compliance with national medical device regulations overseen by the NMPA.