China NMPA Product Recall - EB-1600MD Semiconductor Laser Therapy Machine

Shanghai Yibei Laser Technology Co., Ltd. initiated a voluntary Class III recall for its EB-1600MD semiconductor laser therapy machine, as announced by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration on February 24, 2021. This action addresses a procedural discrepancy rather than a product defect or safety concern. The issue arose because the company utilized a new registration certificate number for production and sales prematurely. Following the renewal of the product's registration in 2020, necessitated by a new national medical device classification catalog implemented in August 2018, the company began using the updated certificate number before its official recordation was finalized in the product registration form. The recall specifically targets machines manufactured and sold after the previous registration certificate's expiration in February 2021. Shanghai Yibei Laser Technology Co., Ltd. clarified that this recall does not involve product defects or pose any safety risks, with detailed affected product information available in the "Medical Device Recall Event Report Form."