China NMPA Product Recall - Transcranial Doppler Blood Flow Analyzer (Non-invasive Vascular and Transcranial Doppler Systems)

Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. has initiated a voluntary Class III recall of its Non-invasive Vascular and Transcranial Doppler Systems, identified by Registration Certificate No. 20183232007. This action follows findings during a 2021 national spot check conducted by the National Medical Products Administration (NMPA). The primary issues identified were non-compliance with national standards GB 9706.1-2007 and GB 9706.9-2008. Specifically, the products were found to lack essential power supply voltage and other required markings. Furthermore, the systems failed to display the skull thermal index (TIC) in real time, which is a critical safety and operational requirement. In response to these compliance deficiencies, the company is undertaking this recall to address the identified product shortcomings and ensure adherence to regulatory specifications. Detailed information regarding affected models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the importance of medical device manufacturers meeting stringent regulatory standards to ensure product safety and functionality.