China NMPA Product Recall - Transcranial Doppler ultrasound blood flow analyzer

Shenzhen Delikai Medical Equipment Co., Ltd. initiated a voluntary Class III recall of its Transcranial Doppler Ultrasonic Blood Flow Analyzers. This action, published by the National Medical Products Administration (NMPA) on July 5, 2021, under Index Number JGXX-2021-10338, was prompted by a significant printing error on the product labels. Specifically, the crucial mark indicating the liquid ingress protection level was missing. This omission could potentially mislead users regarding the device's environmental resistance, which is essential for its safe application in clinical environments. While specific inspection dates are not detailed in this document, the recall underscores the NMPA's regulatory framework for ensuring the safety and quality of medical devices in China. Shenzhen Delikai's required action involves recalling the affected products, with comprehensive details on models, specifications, and batches provided in an accompanying "Medical Device Recall Event Report Form." This ensures compliance with regulatory standards and mitigates potential risks to end-users from improperly labeled medical equipment.