China NMPA Product Recall - Optometry

Shanghai Xiongbo Precision Instruments Co., Ltd. commenced a voluntary Class III recall of its optometristors, a measure publicly announced by the National Medical Products Administration (NMPA) on July 14, 2017. The central concern leading to this recall was a critical omission within the product manuals: the failure to accurately include the model and rating specifications for the fuses integrated into the devices. This informational discrepancy necessitated immediate corrective action to uphold product safety standards and ensure full regulatory compliance. The affected product is identified under Registration No.: 沪食药监械( 2221247号). This voluntary recall signifies Shanghai Xiongbo's proactive engagement in addressing product deficiencies under the oversight of the NMPA, the primary regulatory body for medical devices in China. The company's required action involves retrieving the non-compliant devices from the market, with comprehensive details regarding specific affected product models, specifications, and batch numbers being outlined in an accompanying "Medical Device Recall Event Report Form." This incident highlights the importance of precise documentation and adherence to established regulatory guidelines for medical device manufacturers, ensuring transparency and user safety.