China NMPA Product Recall - Specific Electromagnetic Wave (TDP) Therapy Device

Chongqing Hualun Hongli Industrial Co., Ltd. initiated a voluntary Class III recall of specific Electromagnetic Wave Therapy Devices (Model CQH-25A, Registration No. Wei (Zhun) 2014 No. 2260068). This action, reported to the National Medical Products Administration (NMPA) via the Chongqing Municipal Drug Administration, stemmed from devices produced on January 9, 2018, failing to meet crucial "voltage and/or energy limitations" requirements. The identified non-conformity presented a potential safety hazard, necessitating the removal of affected products from circulation. The recall involved 65 units from batch 1801041, which were primarily sold within China for adjunctive treatment of soft tissue injuries, cervical spondylosis, lumbar spondylosis, and arthritis. To address the issue, Chongqing Hualun Hongli Industrial Co., Ltd. committed to issuing "Medical Device Recall Notices" to all sales units based on their sales lists. Medical institutions and operating units that received these devices are mandated to comply with the instructions outlined in the customer notifications, ensuring proper handling and disposition of the recalled products. This proactive measure aims to mitigate risks associated with the defective devices and uphold product safety standards under the NMPA's regulatory oversight.