China NMPA Product Recall - Semiconductor laser therapy machine

Shanghai Yibei Laser Technology Co., Ltd. announced a voluntary Class III recall for its semiconductor laser therapy machine, identifiable by Registration Certificate No. 20163240184. This recall, publicized on June 29, 2019, stems from critical non-compliance issues discovered during a 2019 spot check conducted by the National Medical Products Administration (NMPA). The investigation revealed two main concerns. Firstly, the actual input power of the semiconductor laser therapy machine was found to exceed the power value explicitly stated in the device's instruction manual. Such a discrepancy is significant as it could impact device performance and user safety. Secondly, the instruction manual presented an outdated version number from 2001, which did not correspond with the product's current 2012 registration version. This inconsistency in documentation indicates a failure to maintain accurate and up-to-date product information as required by regulatory standards. Operating under the oversight of the NMPA, and registered with the Shanghai Food and Drug Administration, Shanghai Yibei Laser Technology Co., Ltd. initiated the recall to rectify these issues. The required action involves retrieving affected units to ensure all product specifications and associated documentation align with approved regulatory parameters. Further specifics regarding affected product models, specifications, and batch numbers are provided in the comprehensive 'Medical Device Recall Event Report Form' made available by the company.