China NMPA Product Recall - Carbon dioxide laser therapy machine (Model: JZ-3D)

Hefei Anheng Optoelectronics Co., Ltd. has initiated a voluntary Class III recall for its JZ-3D Carbon Dioxide Laser Therapy Machine. This decision, announced on July 5, 2021, follows the product's failure to meet standards during a random inspection conducted by an unspecified entity. The specific recalled devices are identified by registration number "国械注准20173240315". This regulatory action falls under the oversight of China's National Medical Products Administration (NMPA). While the document confirms the inspection failure, it does not detail the exact nature of the non-conformity. A Class III recall typically indicates that exposure to the product is unlikely to cause severe adverse health consequences. Hefei Anheng Optoelectronics Co., Ltd. is responsible for implementing this recall to address the identified issue, ensuring compliance with NMPA's regulatory framework and product safety standards. Further comprehensive details, including specific batch numbers and affected models, are documented in the official "Medical Device Recall Event Report Form."